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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 10  |  Issue : 1  |  Page : 12-18

Clinical study to compare effect of Haridradi lepa and Shringatadi tailam along with Shwadanshtradi churna in Keshashatan (hair fall)


1 Department of Agad Tantra, RGGPGA College Paprola, Paprola, Himachal Pradesh, India
2 Department of Agad Tantra, National Institute of Ayurveda, Jaipur, Rajasthan, India

Date of Submission08-Nov-2021
Date of Decision04-Jan-2022
Date of Acceptance24-Jan-2022
Date of Web Publication31-Mar-2022

Correspondence Address:
Dr. Rajveer Sason
Department of Agad Tantra, RGGPGA College Paprola 176115, Paprola, Himachal Pradesh.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JISM.JISM_87_21

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  Abstract 

Background: Hair loss affects people of all gender, ages, and ethnicities, and it has both physical and psychological consequences. In today’s world, chemical hair treatments such as bleaching, straightening, relaxing, or permanent waving are very popular. Aims and Objectives: The purpose of this study was to evaluate the effect of Haridradi lepa and Shringatadi tailam along with Shwadanshtradi churna on hair loss and to research the literature on hair loss. Materials and Methods: A total of 90 patients with hair fall diagnosed clinically were enrolled and divided into two groups randomly. The duration of the trial was 2 months. There were 45 patients in each group. Cases were diagnosed using clinical signs of hair loss as described in classics. For male pattern baldness, the modified Norwood–Hamilton scale was used. For female hair loss, the Ludwig scale was used. Results and Conclusion: The percentage relief of the Sammuchya lakshnas (overall symptoms) was maximal 35.6% with P-value 0.0156 for the Study Group A patients and 44.6% with P-value 0.0136 for Study Group B patients, according to the research. The statistical study revealed that both groups improved significantly.

Keywords: Cosmetics, hair fall, Kesha


How to cite this article:
Sason R, Sharma A. Clinical study to compare effect of Haridradi lepa and Shringatadi tailam along with Shwadanshtradi churna in Keshashatan (hair fall). J Indian Sys Medicine 2022;10:12-8

How to cite this URL:
Sason R, Sharma A. Clinical study to compare effect of Haridradi lepa and Shringatadi tailam along with Shwadanshtradi churna in Keshashatan (hair fall). J Indian Sys Medicine [serial online] 2022 [cited 2022 May 27];10:12-8. Available from: https://www.joinsysmed.com/text.asp?2022/10/1/12/342312




  Introduction Top


Background

Hair that is healthy, long, and vibrant can significantly improve one’s personality. As a result, maintaining good hair is solely the responsibility of humans, as hair, like the face, is a reflection of one’s overall health. Humans are given with a lot of sophistication and pleasure in this advanced civilized period, but they are also left with a sedentary lifestyle, stress-induced hectic schedules, and poor food habits. All of these practices have an impact on the body’s homeostasis, which can lead to a variety of health issues, including falls.[1] This is a major subject that humanity has been grappling with for millennia, and the answer can be found in Ayurveda. According to Acharya, in order to save our lives, we must follow certain life norms such as “Dincharya, Rutucharya, and Achar rasayan” for a healthy state of mind.[1]

By the age of 50, alopecia affects 30%–50% of men. Luxurious hair is associated with youth, attractiveness, and good health in almost every community on the planet.[1]

Hair loss is caused by a variety of etiological reasons. Hair fall due to hormonal imbalance, nutritional deficiency, and stress; hair fall after systemic disorders such as hyperpyrexia, thyroid malfunction, and severe infection; hair fall due to mechanical damage and chemical treatment of the hair like shampoo or hair dye containing strong chemicals like selenium bleach; and hair fall due to mechanical damage.[2]Asthi dhatu (bony tissue) is the source of hair. The hair’s Snigdha guna (smoothness) is for Mrudatv and Adartva.[2] When this lower, hair issues such as hair loss, dandruff, split ends, and baldness develop. The excessive use of external applications such as shampoos, dyes, oils, lotions, and chemicals nowadays cause hair to become fragile and dry due to the Ruksha guna (dryness) of these products exacerbating Vata, resulting in hair breakage and other issues.[2] Hair loss owing to the application of a poisoned plaster to the head is also described in Sushrata Samhita Kalpa Sathan 1/55,[3] along with symptoms such as headache, bleeding from the mouth and nose, and the formation of eruptions on the head. The purpose of this trial was to compare the effect of Haridradi lepa and Shringatadi tailam along with Shwadanshtradi churna on hair fall.


  Materials and Methods Top


Trial Design

This is a randomized, open-label, comparative clinical study. The trial got cleared by the institutional ethics committee (IEC/ACA/2018/2/23) and was registered retrospectively in the Clinical Trials Registry of India (CTRI/2019/06/019906 [Registered: 27/06/2019]).

Method of Collection of Data

Participants

A total of 90 people were chosen at random, ranging in age from 20 to 70 years, regardless of sex, religion, or other factors. A carefully created case record format was used to collect all essential information.

Randomization

The allocation of patients was done using the random table method.

Informed Consent

A full interrogation and explanation about the nature of the disease and the possible application site reactions of the treatment were explained to each patient. Then signed, written informed consent was taken from each patient before starting the trial.

Inclusion Criteria

Patients in the age group 20–70 years of either gender visiting the Out-Patient Department (OPD) and willing to provide written, informed consent were selected to the study on the basis of specially prepared performa.

Exclusion Criteria

The following patients were excluded: patients who have been diagnosed with a local condition such as alopecia errata, alopecia totalis, tinea capitis, folliculitis decalvans, or Arunshika in Ayurveda words, and baldness; patients with any type of cancer, diabetes, heart disease, HIV, and so on; and patients who have been on steroids or have a history of long-term steroid or chemotherapeutic drug use.

Diagnostic Criteria

As per the clinical features of hair fall mentioned in classics, cases were diagnosed.

Assessment Criteria

Subjective criteria

The patients with the clinical signs and symptoms as per Ayurveda as well as modern texts were considered. For the purpose of perfect diagnosis and assessment, a special research performa was utilized.

Scoring criteria

To facilitate the statistical analysis of the effect of therapy, scoring system was adopted. Cessation of hair fall was measured as a main feature to assess the effect of therapy. Other associated symptoms such as dryness and dandruff were also considered, but the main emphasis was laid on the stoppage of hair fall. For male pattern baldness, the modified Norwood–Hamilton scale was used. For female hair loss, the Ludwig scale was used.

Study Objective and Outcomes

The primary objective of the study was to evaluate the effect of Haridradi lepa and Shringatadi tailam on hair fall over a period of 2 months. Secondary outcomes included a comparative assessment of the effect of Haridradi lepa and Shringatadi tailam on hair fall.

Interventions

A total of 90 clinically diagnosed patients of cosmetic-induced hair fall were divided randomly into two groups. Both groups had 45 patients.

Trial Drug Preparation

Both drugs were prepared in the Shree Ram Pharmacy, Jaipur, Rajasthan.

Group A

Hair fall was treated locally with Haridradi lepa[4] [Table 1] and internally with Shwadanshtradi churna[5] in 45 clinically diagnosed and registered patients for 60 days.
Table 1: Showing ingredients of Haridradi lepa

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Dose

Lepa once weekly for 2 months with navneet (butter) and 3 g churna (powder) twice daily with madhu (honey).

Group B

Hair fall was treated locally with Shringatadi tailam[6] [Table 2] and internally with Shwadanshtradi churna [Table 3] in 45 clinically diagnosed and registered patients for 60 days.
Table 2: Showing ingredients of Shringatadi tailam

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Table 3: Showing ingredients of Shwadanshtradi churna

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Dose

70 ml\week oil for external application and 3 g churna twice daily with madhu (honey).

Follow-Up

All patients were followed every 15 days for total 60 days, advised with adequate athya and apathya (wholesome and unwholesome).

Observations

The various observations are made in the clinical study as summarized below:

Age

In the present study, 39% subjects belonged to the age group 20–30 years.

Sex

In this clinical study, the observation shows that the maximum number of patients were female, i.e. 63 (70%), and 27 (30%) were male.

Religion

It was found that 78% were Hindu; the study record shows the maximum occurrence in Hindu compared to other religion.

Occupation

The study shows that 23.33% patients belonged to business class, 18.88% were students, and 27.77% were in job. The percentage of farmers and labors were 3.33% and 8.88%, respectively.

Chronicity

In the present study, the maximum number of patients, i.e. 35.55%, were having chronicity 2–5 years followed by 26.66% patients having a history of 0–1 year and 24.44% patients having a history of 1–2 years. In all, 13.33% patients had chronicity of 2–5 years.

History of treatment

In this study, the patients had history of treatment of Allopathy, Homeopathy, Unani, and Ayurveda. However, the maximum number of patients, i.e. 62.22%, were taking allopathy treatment.

Agni

In the present clinical study, the maximum number of patients, i.e. 63.33%, were having Mandagni, followed by 16.66% patients having Vishamagni. While Samagni patients were 8.88%.

Ras predominancy

Majority of the patients, i.e. 87.7%, were having Lavan rasa-dominant diet, followed by Katu rasa (44.4%), Madhura rasa (57.7%), Amla rasa (64.4%), and Tikta rasa (58%).

Material Used for Hair

A total of 88.8% patients used shampoo for washing purpose, whereas some other 30% used soap for washing their hairs. Some shampoos and strong soap (contain fatty acid and salts) make hair root dry that damages hair. In all, 42% of the patients used dye/cream/lotion, which causes dandruff and leads to hair loss. A total of 60% patients used hard water for hair washing.

Chief Symptoms

Keshashatan (hair fall)

Hair fall was found in 100% patients.

Kesharukshatva (dryness of hair)

70% patients were having Ruksha hair, which indicate some abnormality in the sebaceous gland of hair follicle.

Darunaka (dandruff)

It was found in 52.5% patients. This indicates that it is one of the aggravating factors for premature hair fall.

Keshabhoomi-kandu (itching on scalp)

It was found in 85.5% patients, which indicates Swedadhiktata and Kaphadushti.


  Result Top


With the use of statistical tools, the therapeutic results were analyzed in two steps. The first phase entails analyzing each group separately before and after therapy. The intergroup evaluation or between-group evaluation of both therapies was the second step. The Wilcoxon matched-pairs signed-ranks test was used to assess the effect of therapy on subjective parameters for intragroup comparison [Table 4]. The Mann–Whitney test was used to compare the efficacy of two medicines in an intergroup comparison [Table 5].
Table 4: Showing the effect of therapy on subjective parameters (Wilcoxon matched-pairs signed-ranks test)

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Table 5: Intergroup comparison of Group A and Group B (Mann–Whitney test)

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Overall effect of therapy

The overall relief of the treatment was noted [Table 6]. In all, 52.5% patients showed moderate relief, 35% patients showed marked relief, 10% patients showed mild relief, and 2.5% patients showed excellent relief. The analysis of the relief percentage of the overall symptoms show that the relief for Study Group A patients was 35.6% and the relief for Group B patients was 44.6%. The statistical analysis showed that the improvements in both groups were significant.
Table 6: Overall effect of therapy as per Sammuchya lakshana (overall symptoms)

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  Discussion Top


Hair loss, while considered a cosmetic concern, may cause a great deal of psychological distress, and there is a paucity of literature in the Indian subcontinent about this disfiguring and unpleasant condition. Various diseases are caused by Hina, Mithya, and Aatiyoga of Aahara, Nidra, and Bhramachaya, Virudh aahara vihara (incompatible food), and Pitta vardakas aahara vihara. Both drinking contaminated water and living in a dirty environment are bad for health. The use of oil on the scalp, as well as the consumption of Dushi visha (cumulative poison), is not advised. The presence of redness on the scalp suggests Pitta involvement. Hair breakage can be caused by overuse of hair clips.[2] In today’s world, chemical hair treatments such as bleaching, straightening, relaxing, or permanent waving are very popular. Hair loss can be caused by certain hairstyles that put persistent tension on the hair follicle. The stress applied to the root causes damage to the hair follicle, resulting in traction alopecia. Because of the tightness of these styles and the heavy pressure on the scalp, they might cause follicular damage.[2]

While hairstyling is the most prevalent cause of traction alopecia, it can also happen as a result of forceful combing or brushing, such as nit combing following a head lice infestation. As a result, herbal formulations are required to provide treatment to patients suffering from hair loss. The current clinical investigation focuses on the usage of Haridradi lepa and Shringatadi tailam, as well as Shwadanshtradi churna. Haridradi lepa contains Haridra, which aids in the rejuvenation of scalp health and the prevention of itching and hair loss. Shringatadi tailam also contains medications such as Triphala, which can aid in Vatashaman and also alleviate dryness caused by hair products, hence reducing hair fall. The majority of the patients who signed up for the clinical trial were from the National Institute of Ayurveda hospital’s OPD unit in Jaipur. The experiment was split into two groups: Group A and Group B. In all, 45 patients with hair fall were given Haridradi lepa and Shwadanshtradi churna in Group A; meanwhile, Shringatadi tailam and Shwadanshtradi churna were given to 45 patients with hair fall in Group B. Both groups were provided a typical diet. Before and after therapy, patients who were registered for hair loss were assessed using several measures such as the Ludwig scale and the Hamilton scale. Before and after treatment, some complaints were assessed using traditional signs and symptoms such as Keshashatan (hairfall), Darunaka (dandruff), and Kesharukshatva (dryness).[7]

Discussion on Intergroup and Intragroup Comparison

Group A showed 51% improvement in the hair fall score as compared to Group B having 65% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically significant result (P-value = 0.0390), which states that there is a significant difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group B showed slightly better results over Group A. Group A showed 53% improvement in hair fall score as compared to Group B having 83% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically significant result (P-value <0.0001), which states that there is a significant difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group B showed slightly better results over Group A. Group A showed 60% improvement in the hair fall score as compared to Group B having 76% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically non-significant result (p value <0.0001), which states that there is a significant difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group B showed slightly better results over Group A. Group A showed 78% improvement in the hair fall score as compared to Group B having 67% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically non-significant result (P-value = 0.551), which states that there is no difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group A showed slightly better results over Group B. Group A showed 55% improvement in the hair fall score as compared to Group B having 59% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically non-significant result (P-value = 0.014), which states that there is a significant difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group B showed slightly better results over Group A. Group A showed 52% improvement in the hair fall score as compared to Group B having 47% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically non-significant result (P-value = 0.996), which states that there is no difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group A showed slightly better results over Group B. Group A showed 10.9% improvement in the hair fall score as compared to Group B having 26.5% relief, and statistically, the result was highly significant in both groups. An intergroup comparison showed statistically non-significant result (P-value = 0.102), which states that there is no difference between the efficacy of trial drugs of both groups. In the terms of percentage improvement, Group B showed slightly better results over Group A. The overall relief of the treatment was noted. In all, 52.5% patients showed moderate relief, 35% patients showed marked relief, 10% patients showed mild relief, and 2.5% patient showed excellent relief [Chart 1].
Chart 1: Consort chart of the study

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Discussion on Effect of Therapy

The analysis of the relief percentage of the Sammuchya lakshnas (overall symptoms) shows that the percentage relief for Study Group A patients was maximum 35.6% and the relief for Group B was 44.6%. The statistical analysis showed that the improvements in both groups were significant. In the present study, Group A and Group B drug showed highly significant results in the reduction of hair fall (Keshashatan), Darunaka (dandruff), and Keshabhoomi-kandu (itching on scalp). Group A showed highly significant results in Kesharukshatva (dryness of hair); on the other hand, Group B showed statistically significant result. Both groups showed highly significant results on increasing resistance of hair to the hair-pull test. Drugs of both groups showed non-significant results on new hair growth as per the modified Norwood–Hamilton scale for male pattern baldness and the Ludwig scale for female hair loss. In the present clinical trial, duration of 2 months was very short because new hair growth was not possible in this duration. So it was very difficult to assess the score as per the modified Norwood–Hamilton scale for male pattern baldness and the Ludwig scale for female hair loss. In the overall assessment of therapy also, better results were observed by the Group B drug over the Group A drug.

Probable Mode of Action of the Drug

Shringatadi tailam

Shringatak, Haritaki, Bhibhitaka, Amalaki, Bhringraj, Neelkamal, Loha bhasma, and Tila tailam are the components in this oil. The medications have Keshya (hair tonic), Vishaghna (antitoxic), Jantughna (antibacterial), Daurgandhya-Nashaka, Kandughna (antipruritic), and Srotoshodhan characteristics.[8] Thiamine, riboflavin, oxalate, amylase, copper, and manganese present in Shringatak helps to strengthen hair. Amalaki contains vitamin C, carotene, nicotinic acid, riboflavin, tannin, and ellagic acid, which help in providing natural antioxidants. Ediptual (α-terthienyl aldehyde) and α-iterthienyl-methanol in Bhringraj maintain hair texture and prevent hair fall. These constituents were constructed according to “Sanskaro hi Gunantaradhanam” by the Snehapaka vidhi, and their separate properties change and new properties develop. As a result, the Taila (oil) is prepared with Laghu, Sukshma, and Snigdha gunas; Tikta and Katu rasa; Katu vipaka; and Ushnavirya, with the intention of achieving a Tridosha shamaka effect.[9]

Haridradi lepa

The powder form of Haridradi lepa with Navneet (butter) was used in trial Haridradi lepa, which contains Haridra and Daru haridra, which aid in the rejuvenation of scalp health and the elimination of itching and hair loss. Haridra is a rhizomatous spice that has been used in India from ancient times. Katu-tikta ras, Rukhsha, Laghu guna, Ushnavirya, Vipak katu, and Tridosha shamaka properties are the various pharmacological properties of Haridra. Haridra’s shothghna activity is caused by its Kapha and Vata Shamaka properties.[10]

Extracts of turmeric used in the treatment of androgenic alopecia is carried out in various laboratory studies.[11] Several studies have also shown that Haridra has anti-inflammatory properties. Turmeric has antioxidant, anti-inflammatory, and antibacterial properties. Its essential oil, which contains ar-turmerone as a primary component, has been proven to have anti-inflammatory effects.[12] Turmeric can moisturize and rejuvenate skin while also reducing dryness. Its antiseptic and anti-inflammatory properties can aid to soothe and relieve dandruff. Curcuminoids, the main component of plants, aid in the treatment of androgenic alopecia. Finasteride works by lowering the body’s capacity to convert testosterone to dihydrotestosterone (DHT).[13]Daruharidra has the qualities of lightness, dryness, Vishada guna, non-adhesiveness, as well as Tikta, Kashaya rasatmak, hot potency, and pungency. Daruharidra also possess characteristics such as Chedana (removal, destruction), Lekhana (scrapping), Shodhana (purification), Kapha-Pitta nashana (pacification), Vishanashana (antitoxic treatment), Vedanashamana, and Twak-doshahara (alleviates vitiated skin).[2] It acts as Shamak (Pachan of doshas) Rakta shodhak (blood purifier), Twak doshahara due to its Tikta and Kashaya rasa.[10] The extracts were also evaluated for antioxidant and lipid peroxidation activity by 1,1-diphenyl-2-picrylhydrazyl and thiobarbituric acid reactive substances (TBARS) method, respectively. The study throws a limelight on the use of Berberis aristata DC in the prevention and treatment of acne and hence can be used in Darunak also.[10] Due to its Katu vipak, it acts as Kaphghna, whereas it acts as Lekhaneeya due to its Ruksha and Laghu guna. Tikta, Kashaya rasa, Ushna, Virya, Katu vipaka, and Rukshaguna provide a synergistic effect. Furthermore, Ushnata aided in the growth of local blood supply, hence increasing feeding. The medications’ qualities of Kledashoshaka, Lekhana, and Doshnashaka assisted in the clearance of obstruction.[14] This lepa with navneet helps in absorbing and also counteract Rukshta and Ushnta caused by Haridra and Daru haridra.

Shwadanshtradi churna

Inadequate nourishment can also cause hair root function to deteriorate. Because premature hair loss is an indication of early aging, Rasayana therapy (rejuvenation) was used to counteract the excessive catabolic process. Shwadanshtradi churna was chosen for oral administration because it is a combination of the medications Gokshura, Guduchi, and Amalaki, all of which have Keshya (hair tonic) and Rasayana (rejuvenation) qualities. Shwadanshtradi churna, by its Rasayana action, reduces Tridoshaghna karma and Prabhava in the current study. Agni deepana occurs, followed by Rasadi dhatu poshana, which leads to Shiro tarpana.[14]


  Conclusion Top


In this trial, it is concluded that the most vulnerable age for the onset is between the ages of 20 and 30. It can be stated that persons who consume a predominantly Lavan rasa and Tikta rasa diet are more vulnerable to the disease. Excessive usage of Kshara, according to Ayurveda texts, is the cause of this ailment, although we found no such patients in our study. During the trial, no adverse effects of the medication were discovered. In the current trial, both Group A and Group B drugs significantly reduced hair loss, dandruff, and dryness of hair. In Keshabhoomi-kandu (pruritus), both Group A and Group B drugs exhibited considerable results (itching on scalp). The medicines in Group B outperformed the medicines in Group A in terms of whole therapy evaluation.

Financial Support and Sponsorship

Nil.

Conflicts of Interest

There are no conflicts of interest.



 
  References Top

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Conant NF, Smith DT, Baker RD, Callaway JL Manual of Clinical Mycology. 3rd ed.Philadelphia, PA: WB Saunders Co.; 2008. p. 644-53.  Back to cited text no. 1
    
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Sharma N, Yadav Y, Sharma U, Sharma KC Concept of hair and hair diseases in Ayurveda. IJRMST2019;8:712-20.  Back to cited text no. 2
    
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Shastri A Rasratna Samucchya. 11th ed. 24/85. Varanasi: Chaukhamba Sanskrit Sansthan; 2008. p. 184.  Back to cited text no. 4
    
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Tripathi B Ashtanga Hridayam. Uttarsthana, 39/159.Delhi: Chaukhambha Bharati Academy; 2014. p. 67.  Back to cited text no. 6
    
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Tripathi B Ashtanga Hridayam. Sharir sthan 5/14.Delhi: Chaukhambha Bharati Academy; 2014. p. 101.  Back to cited text no. 7
    
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Pharmacopoeia Commission for Indian Medicine & Homeopathy. Ayurvedic Pharmacopoeia of India. 1st ed. Vol 1. New Delhi:Ministry of Health & Family Welfare; 1986.  Back to cited text no. 8
    
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Manosroi J, Jantrawut P, Manosroi W, Kongtawelert P, Manosroi A 5α-Reductase inhibition and melanogenesis activity of sesamin from sesame seeds for hair cosmetics. Chiang Mai Journal of Science 2015;42:669-80.  Back to cited text no. 9
    
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Sharma PC Database on Medicinal Plants Used in Ayurveda. Vol 1. New Delhi: Central Council for Research in Ayurveda and Siddha; 2000. p. 152-4.  Back to cited text no. 10
    
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Vaughn AR, Branum A, Sivamani RK Effects of turmeric (Curcuma longa) on skin health: A systematic review of the clinical evidence. Phytother Res 2016;30:1243-64.  Back to cited text no. 11
    
12.
Swerdloff RS, Dudley RE, Page ST, Wang C, Salameh WA Dihydrotestosterone: Biochemistry, physiology, and clinical implications of elevated blood levels. Endocr Rev 2017;38:220-54.  Back to cited text no. 12
    
13.
Martin KW, Ernst E Herbal medicines for treatment of bacterial infections: A review of controlled clinical trials. J Antimicrob Chemother 2003;51:241-6.  Back to cited text no. 13
    
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Gyanendra Pandey Dravyaguna Vijana. Vol 3, 3rd ed. Varanasi: Chaukhamba Krishna Das Academy; 2014. p. 410-5.  Back to cited text no. 14
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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