• Users Online: 200
  • Print this page
  • Email this page


 
 
Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 10  |  Issue : 1  |  Page : 6-11

A comparative study to evaluate the efficacy of an oral Ayurveda compound and Panchakarma procedures in conjunction with physiotherapy in delayed milestones status of cerebral palsy


1 Department of Kaumarbhritya, Government Ayurveda College and Hospital, Bilaspur, Chhattisgarh, India
2 Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur, Rajasthan, India

Date of Submission26-Nov-2021
Date of Decision01-Feb-2022
Date of Acceptance07-Feb-2022
Date of Web Publication31-Mar-2022

Correspondence Address:
Dr. Vidya Bhushan Pandey
Department of Kaumarbhritya, Government Ayurveda College and Hospital, Senior HIG 03, New Housing Board Colony, Deorikhurd, Torwa, Bilaspur 495004, Chhattisgarh.
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JISM.JISM_95_21

Rights and Permissions
  Abstract 

Introduction: Cerebral palsy (CP) presents the basic problem of gross delay in the achievement of milestones according to age, especially the motor ones. The study was planned to assess the comparative efficacy of Ayurveda drugs and procedures in the achievement of milestones in conjunction with available standard management physiotherapy (PT). Materials and Methods: Three basic milestones neck holding, sitting, and standing was assessed over statistical parameters with the help of the CDC scale of milestone development. Three groups (Gp.) A B and C were made, Gp. A having PT alone was compared with Gp B with Panchkarma (PK) and PT and Gp. C with PK, PT, and oral drugs. Standard available treatment PT was provided in all the groups. Treatment was provided for 6 months and follow-up after every 2 months. Results within the group were assessed with the Student’s t test and intergroup comparison with ANOVA. Results: Total 51 cases registered and randomly allocated to different groups having 17 cases in each, 6 cases in each group have discontinued and the results were drawn having 11 cases per group. After 6 months, Gp. C presents with maximum improvement 75%, 75%, and 85% for neck holding, sitting, and standing, respectively, and holds statistically better results (P < 0.05) in the neck holding scale in intergroup comparison. Discussion: Multimodal treatment is required for the management of primary and associated problems of CP. No sole treatment plan can result in the expected outcome; however, Ayurveda drugs and procedures with PT can provide safe, effective, and speedy achievement of delayed milestones ultimately gaining functional capacities.

Keywords: Ayurveda, cerebral palsy, delayed milestones, Panchakarma, physiotherapy


How to cite this article:
Pandey VB, Kumar A. A comparative study to evaluate the efficacy of an oral Ayurveda compound and Panchakarma procedures in conjunction with physiotherapy in delayed milestones status of cerebral palsy. J Indian Sys Medicine 2022;10:6-11

How to cite this URL:
Pandey VB, Kumar A. A comparative study to evaluate the efficacy of an oral Ayurveda compound and Panchakarma procedures in conjunction with physiotherapy in delayed milestones status of cerebral palsy. J Indian Sys Medicine [serial online] 2022 [cited 2022 May 27];10:6-11. Available from: https://www.joinsysmed.com/text.asp?2022/10/1/6/342107




  Introduction Top


Cerebral palsy (CP) is a non-progressive crippling disease of children with an incidence of 2–2.5/1000 international and 2.95 per 1000 in India.[1],[2] It presents with gross delay in the motor milestones according to a particular age.[3] This delay depends on the number, location, and severity of the lesion in the brain.[3] In Ayurveda, however, there is no direct correlation present with CP but its symptoms like spasticity and rigidity have proximity with symptoms explained under the umbrella term of “Vata Vyadhi” (disorders due to vitiation of Vata Dosha and Avarana) as Kunchana (spasticity) and Stambhana (rigidity), respectively.[4] So, This study was planned with the primary objective of enhancing the functional abilities of CP-affected children with speedy gains in their delayed milestones. Second, preventing further complications so as to improve their quality of life and facilitate early rehabilitation. Ayurveda drugs and procedures with an established role in the pacification of vitiated Vata Dosha resulting in improvement in diseased neuromuscular conditions were evaluated for the effect in delayed milestone management in CP.


  Materials and Methods Top


The study aimed to show the effect of Ayurveda modalities in conjunction with physiotherapy (PT).

Trail design

The research design was a randomized comparative parallel clinical trial divided into three Groups (Gp). Gp A having PT alone, Gp. B having Panchakarma (PK) along with PT, and Gp. C with oral drug in addition to PT and PK.

Participants

Children of age Gp. 1–12 years and diagnosed cases of the spastic type of CP with delayed milestones were included and selected from O.P.D./I.P.D. of Balroga Department in the 2 years of 2009–2011 in a reputed institute of Ayurveda. Patients beyond this age limit, other types of CP, and with progressive neurological were excluded.

Interventions

PT is the standard rehabilitation procedure; it was allowed to continue in all the Gp.s.[5] In the PT, three basic sets of exercises were used for 20 min/two times a day. These are muscle stretching exercises, muscle strengthening, and range of motion exercises selected methodically to benefit CP patients.[5]

PK procedures used in the trial were Abhyanga (local massage) done with the help of Mash Saindhava Sadhita Taila.[6] Once in a day and direction should be towards the heart. Shashtika Shali Pinda Sweda (SSPS), a variant of sudation therapy, where a cooked bolus of Shashtik Shali (Oryza sativa L.) is tied in a cotton cloth and dipped in a decoction of Dashmool and applied on the body.[6]Shirodhara is done by continuously pouring warm liquids prepared with Balamool decoction and an equal amount of warm milk over the frontal aspect of the head. All these three procedures were administered once a day for 20 min, respectively.[6]Matravasti by administering oil medicated with Prasarni (Paederia foetida L.) will be given through an anorectal route once a day.[6] Dose will be 1–3 years 9 mL, 4–5 years 12 mL, and 6–11 years 24 mL and 12 years and above 48 mL. Dose is calculated according to dose of Snehavasti by Acharya Kahsyapa and dose of Matravasti was calculated by doing 1/4th the dose of Snehavasti as told by Acharya Sushruta.[7],[8]

Patta Bandhana (PB), done by applying crepe bandage over PVC plastic splint kept bilaterally posterior and over Popliteal fossa to straighten the lower limbs and bilaterally over the cubital fossa to straighten the hand after PK for 3 h.[9] Only that size of the splint was used which will straighten the joints and the rest of the part will be covered with crepe bandage fabric. Every fourth week of the month all PK procedures are stopped to avoid resistance, whereas PT and oral drug were continued.

Syrup-based oral drug prepared with the 8 evidenced-based medicines given in the dose of 1 mL/kg/day in three divided doses for 6 months.[10] Drugs used in the oral Ayurveda compound were the root of Ashwagandha (Withania somniferous L.), the tuber of Vidarikanda (Pueraria tuberose Willd.), and the bark of Sahinjana (Moringa oliferia Lam.) as two parts and roots of Tagara (Valeriana wellichi DC.), fruits of Amalaki (Emblica officinalis Gaertn.), whole plant of Brahmi (Bacopa monnieri L.) and Mandukparni (Centella asciatica L.) as one part and fruits of Pippali (Piper longum L.) as 1/4th part to prepare the syrup form.[11],[12],[13],[14],[15],[16],[17],[18] This syrup form was an empirical formulation (Anubhuta Yoga) designed according to the evidence-based work of above mentioned drugs in their respective research area. The quantity of raw material for syrup preparation in children was determined by the pharmacy manager of the institute to preserve the taste and required action of the drug.

Outcomes

The expected primary outcome was to identify the changes in milestones followed by secondary outcome to see changes in functional capacities.

Sample size

Considering the prevalence of disability in India as 3.8% the sample size calculated was 31 with a 90% confidence interval and with a 50% dropout rate due to long durational trial 20 more subjects added and the total sample size is drawn was 51 patients.[19]

Randomization Sequence

Simple randomization is done by using table of random numbers from computer-based randomization software.

Allocation

Equal number of participants allocated in all the three groups having ratio of 1:1:1 having 17 patients each arm (3 arms = 51 patients).

Concealment

Mechanism was done by using sequentially numbered opaque sealed envelopes. No blinding was done.

All the ethical considerations along with informed consent related to human participation according to standard guidelines were followed and taken during the study. The effect of the modalities was assessed by the CDC scale of milestones covering three important milestones viz. Neck Holding, Sitting, and Standing.[20]

Statistical methods

Student paired t test was applied for statistical analysis within the Gp. results and Intergroup comparison were done by using the ANOVA test.[21]


  Results Top


At the end, 6 cases in each Gp. (including 2 patients from Gp. A not analyzed for proper interpretation of results) total 18 patients had discontinued might be due to a long durational trial (6 months = 180 days); hence the result was drawn on a total of 33 patients (11 in each group, [Table 1]). As specified in [Figure 1] and [Table 1], the neck holding scale in Gp. A shows a positive change of 15.62% which is statistically significant (P < 0.02) and in Gp. B the result found was 29.41% which is found statistically significant (P < 0.01) whereas in Gp. C changes found were maximum that is 39.39% which is statistically highly significant (P < 0.001). Sitting milestone scale results shows that [Table 1], Gp. A shows 23.81% of changes which is found statistically significant (P < 0.02) and in Gp. B the results found was 38.71% which is also found statistically highly significant (P < 0.001), whereas in Gp. C changes were 55.56% which is statistically highly significant (P < 0.001). In standing milestone scale [Table 1] at the end of trial result in the Gp. A was found 75.00% which is statistically significant (P < 0.05) and in Gp. B the changes were 75.00% which was found statically significant (P < 0.02), whereas in Gp. C the variations found was 85.71% [Figure 2] which was found statistically significant (P < 0.01).
Table 1: Showing results after 6 months of intervention

Click here to view
Figure 1: Consort flow diagram

Click here to view
Figure 2: Showing comparative result of different groups in different Milestone at the end of trial

Click here to view


Intergroup comparison [Table 2] shows that Gp. C was found statistically significant (P < 0.05) over Gp. A, in the Neck holding, whereas in Sitting Gp. B was found statistically significant (P < 0.05) over Gp. A. Other intergroup comparisons, including the standing scale, were found statistically insignificant (P > 0.05). These statistically proven results reject the null hypothesis favoring no significant changes with the use of multimodal therapies.
Table 2: Showing intergroup comparison

Click here to view



  Discussion Top


In this trial, the aim was set to improve the functional capacities of the child. Gp A ended with statistically significant (P < 0.05) results, being with physical therapy as the only standard method of management. Gp. B having PT and PK procedures shown better results than Gp. A, as PK procedures are easier to perform in all the areas of the body than PT especially in spastic cases, resulting from improved blood circulation and power of muscles. The neck region has richer muscle mass than bone mass, and active PT is a difficult task to perform in this area due to its delicacy.

Abhyanga (local Ayurveda massage) and Swedana (fomentation) increase skin and muscular temperature, improve blood circulation and improve the performance of muscle movement, and enhance neck holding.[22],[23] Considering CP nearby to Vatavyadhi in Ayurveda, Abhyanga and Swedana has specified role in pacifying elevated Vata dosha.[24]Abhyanga also produces a typical “Mass reflex” which helps in proper defecation and urination of spastic children which relieves undue stress of constipation.[25] This reflex is especially seen in person with chronic paraplegia in which “Excitatory or inhibitory effects may spread up and down with spinal cord producing discharge of many neurons.”[25] Stimulus generated from Abhyanga and Swedana (fomentation) creates an additional reflex of urination, defecation, and sweating along with their withdrawal response.[25] This additional reflex help in micturition and defecation. In addition to that, some previous researches also show that massage therapy alleviates physical symptoms related to CP and boosts the development process.[26]

Shirodhara relaxes the mind and body and thus lowering the sympathetic tone of the body and inducing relief in spasticity.[27]Matravasti with Prasarni oil locally nourishes the pelvic area due to the lipophilic nature of the rectal mucosa.[28]Vasti is regarded as the Ardhachikitsa (half of the treatment) in Ayurveda, it pacifies Vata dosha in its Moola Pradesh (main region) that is Kati (pelvic region).[29] Pacification of Vata ensures normal function of that region. Short-chain fatty acids of oil medicated with Prasarni (Paederia foetida L.) allow direct absorption of the medicine from epithelial linings to blood capillaries showing its preferred effect.[30] This augments the sitting function in CP-affected children.

Patta Bandhana(PB) is a useful procedure in the management of Kunchana (spastic), Rujarta (painful), and Stabdhagatra (rigidity) conditions of the body.[9] It helps in maintaining proper alignment of hand and legs to support the body weight against gravity as a result of extending body growth in the right direction a proper sitting and standing. Standing is the most difficult and top task in the management of CP to enhance ambulation and was assisted with the proper PB at the spastic lower limbs resulting in appropriate alignment supporting body weight against the reactionary gravitational force. It provides the beneficial advantage of modern bracing when tied with PVC supports preserving its natural functions or reliving rigidity and spasticity.[5]PB especially along with other procedures assisted in proper stretching and thus preventing further contractures and deformities. Modern techniques like “Kinesio taping” are used in CP work by stimulating proprioceptors relieving spasticity and helping in improving gait and ambulatory functions in CP-affected children.[31] These effects are very much similar to the effects of PB.

Gp. C having PT and PK along with syrup-based oral drug, maximum benefits observed in this group due to surplus advantage of evidenced-based oral drugs. Spastic muscle is also a weak muscle due to the regular phase of contraction.[3]Ashwagandha and Tagar help in the relaxation of these muscles.[11],[13]Ashwagandha and Vidarikanda provide proper nutrition to weaken spastic muscles.[11],[12]Ashwagandha, Vidarikanda, and Mandookparni help with peripheral nerve regeneration, synaptic reconstruction, nerve elongation, and neuroprotective properties.[14],[32],[33] These properties enhance the development of a brain function called neuronal plasticity in CP children in which healthy neurons take up the functions of the damaged nerve fiber.[34]Bramhi with cognitive improving functions and anti-convulsive effect of Amalaki helps in the pacification of convulsion which is present as an associated symptom in 50% of CP cases.[15],[16]Shobhanjan and Pippali among all the drugs have a nice immune buildup activity; additionally Pippali provides a benefit of improving the bioavailability of all these drugs thus increasing their therapeutic effect.[17],[18] Conjunct Ayurveda modalities were found significant over gp. A the intergroup comparison which leads to achievement of defined objectives and improving their functional capacities. The study included all the types of delayed milestone patients in the entire group due to limitation of time, duration of interventions and financial assistance. Further division into subgroups that have only unachievable milestones to be assessed and the impact of interventions to be pursued in further research would be preferable.


  Conclusion Top


The observed changes in Gp. C were maximal compared to Gp A and Gp B, with noreported adverse effects of modalities across trials. The safe and effective modalities of Ayurveda along with the standard available treatment process provide better results than standard therapy alone. The results offer a new definition of the multimodal treatment plan for a crippling disorder that impairs growth and development in CP children.

Financial Support and Sponsorship

The drug mentioned was prepared by the Pharmacy of NIA Jaipur, Rajasthan.

Conflicts of Interest

There are no conflicts of interest.



 
  References Top

1.
Reddihough DS, Collins KJ The epidemiology and causes of cerebral palsy. Aust J Physiother 2003;49:7-12.  Back to cited text no. 1
    
2.
Chauhan A, Singh M, Jaiswal N, Agarwal A, Sahu JK, Singh M Prevalence of cerebral palsy in Indian children: A systematic review and meta-analysis. Indian J Pediatr 2019;86:1124-30.  Back to cited text no. 2
    
3.
Yalcin S, Berker N General concept. In: The Help Guide to Cerebral Palsy. 2nd ed. Global Help Health Education Using Low Cost Publication [Internet]. 2010. p. 7-11. [cited 2019 Aug 8]. Available from: www.global-help.org/publications/books/help_C.P.help0cover.  Back to cited text no. 3
    
4.
Das, G, editor. Agnivesha, Charaka Samhita,. Charak Chandrika commentry by Tripathi B. 1st ed. Chikitsa sthana, 28/20–23, New Delhi: Chaukhamba Sanskrit Pratisthan; 2005. p. 938-9.  Back to cited text no. 4
    
5.
Yalcin S, Berker N Bracing. In: The Help Guide to Cerebral Palsy. 2nd ed. Global Help Health Education Using Low Cost Publication [Internet]. 2010. p. 49-53. [cited 2019 Aug 8]. Available from: www.global-help.org/publications/books/help_C.P.help0cover.  Back to cited text no. 5
    
6.
Shrinivasna G Panchkarma llustrated. 1st ed. Delhi: Chaukhamba Sanskrita Prtisthana; 2006. p. 36-205.  Back to cited text no. 6
    
7.
Jivaka. Kashyapa Samhita. Pandit Hemraja Sharma (editor). Vidyotini hindi commentary.Vastivisheshniya Adhyay 8/106–108. 1st ed. Varanasi: Chaukhamba Sanskrit Pratisthan; 2008. p. 285.  Back to cited text no. 7
    
8.
Shushrut, Shushruta Samhita, Shastri AD (editor). Ayurved tatva Sandipika. Netravastipramanpravibhagchikitsa Adhyay 35/18. 1st ed. Varanasi: Chaukhamba Sanskrit Sansthan; 2021. p. 191.  Back to cited text no. 8
    
9.
Shushrut, Shushruta Samhita, ShastriAD (editor). Ayurved tatva Sandipika. Vat Vyadhi Chikitsa Adhyay 4/16. 1st ed. Varanasi: Chaukhamba Sanskrit Pratisthan; 2005. p. 26.  Back to cited text no. 9
    
10.
Singhal HK, Neetu , Kumar A, Rai M Ayurvedic approach for improving reaction time of attention deficit hyperactivity disorder affected children. Ayu 2010;31:338-42.  Back to cited text no. 10
    
11.
Nagarajan D, Karthik G, Duraivelu R, Santhalingam K Phylogenetic analysis and homology based inhibitor design for short neurotoxins of forest cobra. Int J Pharma Bio Sci2011;2:24-35.  Back to cited text no. 11
    
12.
Xu X, Zhang Z Effects of puerarin on synaptic structural modification in hippocampus of ovariectomized mice. Planta Med 2007;73:1047-53.  Back to cited text no. 12
    
13.
Caudal D, Guinobert I, Lafoux A, Bardot V, Cotte C, Ripoche I, et al. Skeletal muscle relaxant effect of a standardized extract of Valeriana officinalis L. After acute administration in mice. J Tradit Complement Med 2018;8:335-40.  Back to cited text no. 13
    
14.
Soumyanath A, Zhong YP, Gold SA, Yu X, Koop DR, Bourdette D, et al. Centella asiatica accelerates nerve regeneration upon oral administration and contains multiple active fractions increasing neurite elongation in-vitro. J Pharm Pharmacol 2005;57:1221-9.  Back to cited text no. 14
    
15.
Pase MP, Kean J, Sarris J, Neale C, Scholey AB, Stough C The cognitive-enhancing effects of Bacopa monnieri: A systematic review of randomized, controlled human clinical trials. J Altern Complement Med 2012;18:647-52.  Back to cited text no. 15
    
16.
Golechha M, Bhatia J, Arya DS Hydroalcoholic extract of emblica officinalis gaertn. Affords protection against Ptz-induced seizures, oxidative stress and cognitive impairment in rats. Indian J Exp Biol 2010;48:474-8.  Back to cited text no. 16
    
17.
Xiao X, Wang J, Meng C, Liang W, Wang T, Zhou B, et al. Moringa oleifera lam and its therapeutic effects in immune disorders. Front Pharmacol 2020;11:566783.  Back to cited text no. 17
    
18.
Sunila ES, Kuttan G Immunomodulatory and antitumor activity of piper longum linn. And piperine. J Ethnopharmacol 2004;90:339-46.  Back to cited text no. 18
    
19.
Pourhoseingholi MA, Vahedi M, Rahimzadeh M Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench 2013;6:14-7.  Back to cited text no. 19
    
20.
CDC. What is a Developmental Milestone? [Internet]. Centers for Disease Control and Prevention. 2021 [cited 2021 Oct 5]. Available from: https://www.cdc.gov/ncbddd/actearly/milestones/index.html. [Last accessed on 2009 Sep 12].  Back to cited text no. 20
    
21.
Home - GraphPad [Internet]. [cited 2021 Oct 5]. Available from: https://www.graphpad.com/. [Last accessed on 2011 Dec 12].  Back to cited text no. 21
    
22.
Weerapong P, Hume PA, Kolt GS The mechanisms of massage and effects on performance, muscle recovery and injury prevention. Sports Med 2005;35:235-56.  Back to cited text no. 22
    
23.
Ahire A, Khati GY, Binorkar S Panchakarma pre procedure and physiotherapy:A unique combination for musculoskeletal disorders. Int Res J India 2016;2:1-9.  Back to cited text no. 23
    
24.
Neelam G, Singh J, Kumar B Role of snehana and svedana in vatavyadhi. Int J Ayu Pharm Chem 2015;1;105-111.  Back to cited text no. 24
    
25.
Premkumar K The Massage Connection Anatomy and Physiology. Philadelphia, PA: Lippincott Williams & Wilkins; 2004. p. 366.  Back to cited text no. 25
    
26.
Hernandez-Reif M, Field T, Largie S, Diego M, Manigat N, Seoanes J, et al. Cerebral palsy symptoms in children decreased following massage therapy. Early Child Dev Care 2005;175:445-56.  Back to cited text no. 26
    
27.
Uebaba K, Xu FH, Ogawa H, Tatsuse T, Wang BH, Hisajima T, et al. Psychoneuroimmunologic effects of ayurvedic oil-dripping treatment. J Altern Complement Med 2008;14:1189-98.  Back to cited text no. 27
    
28.
N R, Gr A, Uppinakudru S Clinical study on the efficacy of Samvardhana ghrita orally and by matrabasti in motor disabilities of cerebral palsy in children. Int J Res Ayurveda Pharm 2013;4:373-7.  Back to cited text no. 28
    
29.
Agnivesha, Charaka Samhita, Gaya das(editor). Charak Chandrika commentry by Tripathi B. 1st ed. Siddhi sthana, 1/39, New Delhi: Chaukhamba Sanskrit Pratisthan; 2005. p. 1169.  Back to cited text no. 29
    
30.
Choudhary K recent advances in ayurvedic management of cerebral palsy affected children. Int J Res Ayurveda Pharm 2014;5:642-7.  Back to cited text no. 30
    
31.
Shamsoddini A, Rasti Z, Kalantari M, Hollisaz MT, Sobhani V, Dalvand H, et al. The impact of kinesio taping technique on children with cerebral palsy. Iran J Neurol 2016;15:219-27.  Back to cited text no. 31
    
32.
Kuboyama T, Tohda C, Zhao J, Nakamura N, Hattori M, Komatsu K Axon- or dendrite-predominant outgrowth induced by constituents from ashwagandha. Neuroreport 2002;13: 1715-20.  Back to cited text no. 32
    
33.
Gadahad MR, Rao M, Rao G Enhancement of hippocampal Ca3 neuronal dendritic arborization by Centella asiatica (Linn) fresh leaf extract treatment in adult rats. J Chin Med Assoc 2008;71:6-13.  Back to cited text no. 33
    
34.
Yalcin S, Berker N Rehabilitation and physiotherapy. In: The Help Guide to Cerebral Palsy. 2nd ed. Global Help Health Education Using Low Cost Publication [Internet]. 2010. p. 40-8. [cited 2019 Aug 8]. Available from: www.global-help.org/publications/books/help_C.P.help0cover.  Back to cited text no. 34
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2]



 

Top
 
  Search
 
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

  Materials and Me...
  In this article
Abstract
Introduction
Results
Discussion
Conclusion
References
Article Figures
Article Tables

 Article Access Statistics
    Viewed986    
    Printed14    
    Emailed0    
    PDF Downloaded139    
    Comments [Add]    

Recommend this journal