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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 10
| Issue : 2 | Page : 79-85 |
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Randomized controlled clinical study to evaluate the efficacy of Pama-Dadru-Vicharchikahar Lepa topically in the management of Vicharchika (eczema)
Amol V Mungale1, Suryaprakash K Jaiswal1, Kirti B Tikhat2
1 Department of Kayachikitsa, DMM Ayurved College, Yavatmal, India
2 Department of Rasashastra, Government Ayurved College, Nagpur, Maharashtra, India
| Date of Submission | 21-Feb-2022 |
| Date of Acceptance | 07-May-2022 |
| Date of Web Publication | 28-Jun-2022 |
Correspondence Address:
Amol V Mungale
Department of Kayachikitsa, DMM Ayurved College, Yavatmal, Parda Taluk, Samudrapur District, Wardha, Maharashtra
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jism.jism_16_22
Background: The worldwide prevalence of eczema ranges from 15% to 20%. The exact cause of eczema is unknown. The modern dermatology employs systemic and local administration of steroid for the management of eczema. Despite an initial response, maintenance therapies with the small dose of systemic and topical glucocorticoid usually produce hazardous ill effect. This study evaluates and compares the effect of both the systems of medicine to get safe and cost-effective treatment. Aim: The purpose of this study was to compare the therapeutic efficacy of Pama-Dadru-Vicharchikahar Lepa (PDVL) to mometasone furoate 0.1% in the treatment of Vicharchika. Materials and Methods: Patients who arrived to the OPD and IPD of the Department of Kayachikita, DMM Ayurved College, Yavatmal, possess Vicharchika’s classical signs and symptoms. In this study, 60 patients enrolled in two groups: 30 patients of group A treated with the local application of PDVL and similarly 30 patients of group B treated with the local application of mometasone furoate 0.1% ointment for 45 days with follow-up of 45 days. The data were compared: Wilcoxon signed rank test was used within each group, whereas the Mann–Whitney test was used between groups. Result: After 90 days of treatment with follow-up, it was found that in the trial group, PDVL, average % relief was 83.86%. In the control group, mometasone furoate 0.1%, average % relief was 79.69%. PDVL was found effective on % relief, safe, easy to administer, and cost-effective. Conclusion: The local application of PDVL is effective than mometasone furoate 0.1% in the management of Vicharchika to reduce Shyava Varna, whereas the local application of PDVL is not effective than mometasone furoate 0.1% topically in the management of Vicharchika to reduce Kandu, Pidika, Rukshata, Strava, Rajyo, Lohit Varna, Ruja, and Eczema Area And Severity Index score. CTRI Number: CTRI/2020/06/025982 Keywords: Eczema, mometasone furoate, Pama-Dadru-Vicharchikahar Lepa, Vicharchika
How to cite this article:
Mungale AV, Jaiswal SK, Tikhat KB. Randomized controlled clinical study to evaluate the efficacy of Pama-Dadru-Vicharchikahar Lepa topically in the management of Vicharchika (eczema). J Indian Sys Medicine 2022;10:79-85 |
How to cite this URL:
Mungale AV, Jaiswal SK, Tikhat KB. Randomized controlled clinical study to evaluate the efficacy of Pama-Dadru-Vicharchikahar Lepa topically in the management of Vicharchika (eczema). J Indian Sys Medicine [serial online] 2022 [cited 2023 Jun 7];10:79-85. Available from: https://www.joinsysmed.com/text.asp?2022/10/2/79/348472 |
| Introduction | |  |
Ayurveda is an ancient Indian holistic and natural healthcare system. Kayachikitsa (medicine) is a specialized branch of Ayurveda dealing with treatment.[1] The majority of skin disorders is caused by improper Agni (fire) functioning, poor dietary habits such as unsuitable foods, irregular meal patterns, and habits such as smoking, alcoholism, and psychological stress, which all contribute to lifestyle-related skin diseases. Eczema is one of the diseases mentioned in the ancient science among the Kushtha (skin disease).[2] The study of the Indian medical literature reveals that the healthy skin is the reflector of human personality. Any affection of the skin is considered as a problem, which is evident from its description under the heading Kushtha illustrative of the disfiguring nature of the disease. There are so many diseases that do not kill but create physical impairment along with psychological stress and strain. Vicharchika (eczema) is one among Kshudra Kushtha (type of skin disease).[3] All skin diseases have Tridoshaj origin; hence, Vicharchika can be explained in a similar way: Kapha causes Kandu (itching), Pitta causes Strava (oozing), and Shyava (blackish discoloration) indicates the existence of Vata. Even though Vicharchika has a Tridoshaj origin, several Acharyas have mentioned Kapha dominances in it. The incidence rate of Eczema is 15%–20% in India as per WHO and is seen among the people of every age group.[4]Vicharchika has been directly related with eczema (dermatitis) in the modern science based on symptoms and pathophysiology: Kandu (itching), Pidika (eruptions), Shyava varna (blackish discoloration), Bahustrava (oozing), Rajyo (marked lining due to the thickening of skin lesion), Ruja (pain), Rukshata (dryness), and Lohit Varna (redness of lesion).
Eczema is a broad term used for many types of skin inflammations. Usually, the itching is the first symptom of eczema; the rash occurs later and is red in color, with eruptions of different sizes; for this reason, eczema is also called as “itch that rashes.”[5] The majority of dermatologists considers dermatitis to be a synonym for eczema.[6] The modern science has made significant advances in recent years, particularly in the field of dermatology and in terms of the availability of potent antibiotics, antifungals, antihistamines, steroids, and other medications, but better management has yet to be discovered. Only a few medications are available for symptomatic relief; however, the world is gradually turning to Ayurveda for disease cures that are both safe and efficient. Ayurveda may make a big difference, especially when it comes to skin issues. The topical application of Pama-Dadru-Vicharchikahar Lepa (PDVL) is proved to be very effective in the treatment of Vicharchika. As Acharya Charaka has categorically mentioned, there are wide varieties of Lepa (external application),[7] and its importance in the topical application of PDVL with Takra (buttermilk) was subjected to clinical trial in this study.
| Objective | | |
Primary Objective
The primary objective is to study the therapeutic effect of PDVL compared with mometasone furoate 0.1% in the management of Vicharchika.
Secondary Objective
The purpose of this study was to determine the therapeutic efficacy of PDVL topically in signs and symptoms of Vicharchika and to see the comparative effect of PDVL and mometasone furoate 0.1% ointment in managing Vicharchika.
| Materials and Methods | | |
Study Design
This is an open-label, randomized, controlled clinical study.
Study Setting
The subjects were recruited randomly from OPD/IPD section of the Departments of Kayachikitsa of DMM Ayurved College and L.K. Ayurved Hospital, Yavatmal, Maharashtra. PDVL was prepared in Rasashala affiliated with L.K. Ayurved Hospital, Yavatmal.
Sample Size Calculation
Sample size calculation (Danniel,1999)[8] was as follows:
Reported prevalence of eczema = 15%–20%.
The highest prevalence rate of 20% was taken for sample size calculation.
n = z2−p(1−p)/e2,
where Z = 1.96 is the level of significance.
P = 20% × 20/100 = 0.20,
(1−p) = 1−0.20 = 0.80,
e = 0.1 (allowable error = 10%), n = sample size,
n = 61.46.
The total of 60 patients was included for this proposed study.
Sample Size
Sixty patients exhibiting Vicharchika’s clinical sign and symptoms were included: 30 patients in the intervention group (group A), whereas 30 patients in the controlled group (group B). (Due to pandemic (COVID-19) and lockdown, a smaller number of patients were coming to OPD, and also at that time, new guidelines were given by the institute to take half sample size. So, here the sample size was reduced to half.)
Methodology
A total of 60 patients were selected at random using the lottery method in this pilot study. Thirty patients were included in each group (group A and group B) as per inclusion criteria. In total, 60 patients were screened, and all had completed the treatment with no dropouts.
Intervention and Follow-up
[Table 1] shows treatment protocol of both groups. The drug used for the trial group was PDVL locally, and for the control group was mometasone furoate ointment locally; study duration is 90 days; the assessment of patient during the treatment—1st, 8th, 15th, 22th, 29th, 36th, 45th day and during the follow-up—60th, 75th, 90th day.
Preparation of Material
Procedure
[Table 2] having all ingredients of above Kalpa were taken in an equal quantity and pounded in a mortar and made it into a paste. It then made into fine powder and mixed thoroughly. Take as much fine powder of mixed Dravyas as you want to pour requisite amount of Takra in Lepa.[9]
Criteria for the Selection of Patient
Inclusive criteria
In the present clinical trial, those patients were selected who fulfill the criteria of inclusion as follows: age group above 16 and below 70 years, patients with Vicharchika’s characteristic signs and symptoms, i.e., Kandu, Pidika, Shyava Varna, Strava, Ruja, Rajyo, Rukshata, and Lohit Varna, and patients willing for clinical trial, irrespective of gender, occupation, religion, and economical barrier.
Exclusive criteria
Patients with following symptoms/disease were not included in the study: age group below 16 years and above 70 years, pregnant and lactating mother, infective origins such as Koch’s, Scabies, Hansen’s disease, fungal infection, Herpes zoster, psoriasis, drug-induced eczema, systemic disorders diabetes mellitus, malignancy, etc.
Criteria for the assessment of patients
In this clinical trial, patients were diagnosed based on Ayurvedic signs and symptoms of Vicharchika (eczema) as well as the modern approach, i.e., subjective criteria.
This is the subjective parameter and its scoring is mentioned in [Table 3].[10]
Criteria for the assessment of overall effect of therapies
- Complete relief: 100%
- Marked relief: >76%
- Moderate relief: 51%–75%
- Mild relief: 26%–50%
- No relief: <25% [Figure 1]
| Observations and Results | | |
In this study, 60 patients of eczema were studied. Patients were closely observed and assessed according to the criteria of assessment. Data of before and after treatment were analyzed statistically. All these observation and results are described as follows.
Group A had the maximum number of patients, 33.33%, in the age group 31–40 years, whereas group B had 43.33%. Out of 60 patients 53.3% male patients were from group A and 40% male patients from group B, whereas 46.67% female patients from group A and 60% from group B. 86.67% were married in both group A and group B, whereas 13.33% were unmarried in both groups.
16.67% patients in group A and 6.67% in group B belong to the upper socioeconomic status (SES), 76.67% in both groups have middle-class SES, and 6.67% in group A and 16.67% in group B have lower-class SES. The maximum number of patients, i.e., 36.67% in group A and 40% in group B, had Vata-Kapha-Prakruti. The maximum number of patients, i.e., 40% in both groups had Vishamagni. The maximum number of patients in group A, 66.67%, and 73.3% patients in group B had Madhya Kushtha. Out of 60 patients, a maximum number of patients, i.e., 80% in group A and 83.33% patients in group B were consuming mixed Ahar.
Statistical Analysis
Wilcoxon signed-rank test was applied to both groups mentioned in [Table 4] separately to observe whether the difference between before the treatment and after the treatment is significant. In the case of symptoms, Kandu, Shyava Varna, Pidika, Rukshata, Strava, Rajyo, Lohit Varna, Ruja, and Eczema Area And Severity Index (EASI) score, in group A and group B, the test has shown significant difference between before the treatment and after the treatment in symptom scores in both the groups. Hence, it is concluded that in group A, i.e., PDVL, and in group B, i.e., mometasone furoate 0.1% locally, has significantly reduced above symptoms of Vicharchika. Comparing group A and group B by Mann–Whitney’s U test, in the case of symptom Shyava Varna, the test has shown a significant difference between mean differences in both group: H1 is accepted and H0 is rejected here; hence, PDVL is effective than mometasone furoate 0.1% locally in the management of Vicharchika to reduce Shyava Varna. | Table 4: Comparison of different symptoms before treatment (0th day) and after the completion of treatment with follow-up (90th day) in Group A and in Group B by applying Wilcoxon signed-rank test with confidence interval (95%), and the level of significance was set at 0.05
Click here to view |
Overall Effect of Therapy
[Figure 2] shows average % relief was 83.86% in group A, whereas in group B, it was 79.69%; hence according to % relief, it was observed that the local application of PDVL and mometasone furoate 0.1% topically both have nearly an equal efficacy in the management of Vicharchika, and the local application of PDVL is found slightly better on the basis of % relief mentioned in [Table 5]. Few symptoms were present in very few patients and hence % relief might have shown such result.  | Table 5: Comparison of % efficacy of treatment between group A and group B
Click here to view |
| Discussion | | |
Vicharchika is a type of chronic skin infection. Eczema or atopic dermatitis is the most common relapsing skin condition in children. When itching is severe in the early stages of Vicharchika, skin integrity may be impaired, resulting in water discharge. Vagbhata states that Vicharchika has a characteristic similar to Lasikadhya, whereas Indu describes it with Jalapraya, i.e., watery discharge. Viruddha, Mithya Ahara, and Vihara, as well as other Nidana, may act as metabolic toxins or other irritants and cause skin sensitization, similar to eczema. Previous work was done on Vicharchika with Nitya Virechan (regular purgation) by Trivritta powder (Operculina turpethum) along with the local application of paste of leaves of Aragvadha (Cassia fistula).[10] It is effective but includes internal medication with the local application. So, we took effort to give the same effect with only local application.
Probable Mode of Action of PDVL
Acharya Sushruta mentioned Lepa (local application) as a cure for it. The local application of Lepa reduces a provoked local Dosha. Furthermore, Lepa (paste) is described by Acharya Charaka as “Sadyah Siddhi Karaka (immediate effect).”[11] The ingredients in Lepa enter the hair follicle and then are absorbed through the Svedavahi Srotasa (sweat channels) and Siramukha (skin pore openings) to produce the desired effects. Most of Dravyas of Lepa have Katu (pungent), and Tikta (bitter) rasa has Kaphashamak property. Vicharchika is Kapha predominance disease and Katu (pungent) vipak acts as Kaphghna. Twak (skin), Rakta (blood), Mansa (muscle), and Lasika (lymph) are Vicharchika’s Dushya. Twak and Lasika are linked to Rasadhatu (channels of lymph) and Rasavriddhi symptoms are identical to Kaphavriddhi. It shows better effect on strotas (channels), which are mainly get vitiated in Vicharchika. Most of the Dravyas from this Lepa show Raktshodhak (blood purifier), Kushthghna (reduce skin diseases), Panchana (improve digestion), Laghu (light), Ruksha (rough), Ushna (hot), and Tikshna (sharp) properties. Antioxidant, Kandughna (reduce itching), Krimighna (antihelminthic), Dadruhara (fungal infection), and Lekhana (scrape), Chakramarda’s beeja (Cassia tora) reduce the symptoms of itching and papules. The antioxidant activity of Thrachrysone isolated from seeds was significantly stronger.[12]Bakuchi (Psoralea corylifolia) acts as Swedjanan (induces sweating) and Kushtaghna (reduce skin diseases); it has volatile oil, which acts as irritant and special action on skin and mucosal layer.[13]Sarshapa (Brassica campestris) shows Vedanasthapana (reduce pain) property.[14]Haridra’s (Curcuma longa) Lekhaniyaguna (scraping property) is beneficial to reduce skin thickness and Vaivarnyata (discoloration) in disease.[15] The Varnya (fairness) property of the Kushtha (Saussurea lappa) drug helps reduce Vivarnata (skin discoloration). Saussurea Radix melanogenesis inhibitory compounds possess potent antillergic, anti-inflammatory, immunomodulatory, chemoprotective, antibacterial, antioxidant, antiulcerogenic, antimicrobial, and anti-fungal properties, according to the recent study.[16]
This study showed a significant reduction on itching, blackish discoloration, papule, dryness, discharge, red ulcers, pain, and EASI score; the test has shown a significant difference between before treatment and after treatment in symptoms scores.
Comparing group A and group B by Mann–Whitney’s U test mentioned in [Table 6], in the case of symptom blackish discoloration, the test has shown a significant difference between mean differences in both group: H1 is accepted and H0 is rejected, so PDVL is statistically significant beneficial to reduce symptom Shyava Varna, whereas in the case of symptoms itching, papule, dryness, discharge, red ulcers, pain, and EASI score, the test has shown an insignificant difference between mean differences of group A and group B. H0 is accepted and H1 is rejected here; hence, PDVL is not effective as mometasone furoate 0.1% topically in the management of Vicharchika to reduce the above symptom expect Shyava Varna (blackish discoloration). | Table 6: Comparison of the effect of treatment in group A and group B (by Mann–Whitney’s U test)
Click here to view |
| Conclusion | | |
The present trial showed a successful management of Vicharchika with external procedures of PDVL. Statistically significant improvement was noticed in the percentage of skin affected by eczema for each body region, i.e., EASI score. In this, Shyava Varna is significantly reduced in the trial group as compared to the control group, and also the reduction in subjective parameters such as itching, papules, dryness, discharge, red ulcers, and pain in both groups. Based on the outcome of this study, it can be said that the external treatment such as local application can be utilized for the successful management of Vicharchika. No complications or adverse effects were observed during the study.
Recommendation
This study can be carried out by taking a large sample size and for a longer duration. There is further scope for new researchers to compare Shamana chikitsa against Shodhana chikitsa.
Declaration of patient consent
The authors acknowledge to having obtained all necessary patient consent forms. The patient(s) has/have consented in the form for his/her/their images and other clinical information to be published in the journal. The patients are aware that their names and initials will not be published, and that while every effort will be taken to keep their identities hidden, anonymity cannot be guaranteed.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Vaghbhat. Sutrasthana 1/5. In: Tripathi B, editor. Ashtanghriday. 7th ed. Varanasi: Choukhamba Sanskrit Santhan Prakashan; 2016. p. 5.  |
| 2. | Tripathi B Sutrasthana 23/5. In: Tripathi B, editor. Gayadas with Charaka Chandrika Commentary. 5th ed. Varanasi: Choukhamba Sanskrit Santhan Prakashan; 2016. p. 324. |
| 3. | Tripathi B Chikistasthana 7/31. In: Tripathi B, editor. Gayadas with Charaka Chandrika Commentary. 5th ed. Varanasi: Choukhamba Sanskrit Santhan; 2016. p. 254. |
| 4. | Silverberg JI Public health burden and epidemiology of atopic dermatitis. Dermatol Clin 2017;35:283-9. |
| 5. | Lionel Fry. An Atlas of Atopic Eczema. 1st ed. Washington: International Publishers in Medicine, Science and Technology; 2003. |
| 6. | Behl PN Dermatitis and Eczema. In: Practice of Dermatology. 8th ed. Delhi: CBS Publisher and Distributor; 2016. p. 127. |
| 7. | Tripathi B Sutrasthana 3/3–7. In: Tripathi B, editor. Gayadas with Charaka Chandrika Commentary. 5th ed. Varanasi: Choukhamba Sanskrit Santhan Prakashan; 2016. p. 61. |
| 8. | Paik Y-h, Ko U-r, Patwary KM Health Research Methodology: A Guide for Training in Research Method. 2nd ed. Geneva: WHO Library Cataloguing in Publication Data; 2001. p. 76. |
| 9. | Sharangdhar. Uttarkhand 11/50. In: Tripathi I, editor. Sharangdhar Samhita. Varanasi: Choukhamba Sanskrit Santhan Prakashan; 2015. p. 262. |
| 10. | Talekar MT, Mandal SK, Sharma RR Clinical evaluation of Trivṛitta powder (Operculina turpethum Linn.) and Aragvadha Patra Lepa (paste of leaves of Cassia fistula Linn.) in the management of Vicharchika (eczema). Ayu 2018;39:9-15. [ PUBMED] [Full text] |
| 11. | Tripathi B Chikistasthana 7/53. In: Tripathi B, editor. Gayadas with Charaka Chandrika Commentary. 1st ed. Varanasi: Choukhamba Sanskrit Santhan Prakashan; 2007. p. 188. |
| 12. | Khare CP, editor. Indian Medicinal Plants, chapter C reprint. New Delhi: Springer Publication; 2008. p. 130. |
| 13. | Khare CP, editor. Indian Medicinal Plants, chapter P reprint. New Delhi: Springer Publication; 2008. p. 523. |
| 14. | Khare CP, editor. Indian Medicinal Plants, chapter B reprint. New Delhi: Springer Publication; 2008. p. 99-100. |
| 15. | Khare CP, editor. Indian Medicinal Plants, chapter C reprint. New Delhi: Springer Publication; 2008. p. 187. |
| 16. | Khare CP, editor. Indian Medicinal Plants, chapter S reprint. New Delhi: Springer Publication; 2008. p. 586. |
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]
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