FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064562 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 16/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study to check the efficacy of Panchakarma procedures in the management of Multiple sclerosis 
Scientific Title of Study   A Pilot Study to evaluate the Clinical Efficacy of an Ayurvedic Treatment Module in the Management of Multiple Sclerosis ( Sarvanga Gatavata) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anagha Sudhir 
Designation  Post Graduate Scholar 
Affiliation  All India Institute of Ayurveda  
Address  Room No.725 Department of Panchakarma, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, South Delhi 110076 India

South
DELHI
110076
India 
Phone  9711852622  
Fax    
Email  anaghasudhir@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanth Dharmarajan 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda  
Address  Room No.725 Department of Panchakarma, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, South Delhi 110076 India

South
DELHI
110076
India 
Phone  9895174060  
Fax    
Email  drprasanthd@gmail.com  
 
Details of Contact Person
Public Query  
Name  ProfDr Anandaraman PV  
Designation  Professor and HOD 
Affiliation  All India Institute of Ayurveda  
Address  Room No.725 Department of Panchakarma, Academic block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, South Delhi 110076 India

South
DELHI
110076
India 
Phone  9495130595  
Fax    
Email  dr.ananthramsharma@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anagha Sudhir  All India Institute of Ayurveda  Department of Panchakarma, OPD no.6, Hospital block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi - 110076 South Delhi
South
DELHI 		 9711852622

anaghasudhir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Division of Translational Research & Biostatistics, All India Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G35||Multiple sclerosis. Ayurveda Condition: SARVANGAVATAH/SARVANGAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-svedana-karma, स्वेदन-कर्म (Procedure Reference: Dharakalpah, Procedure details: Shashtika shali Pinda Swedan will be done using pottalis filled with bolus of shashtika shali rice processed in the milk decoction of bala. The pottalis will be dipped in milk decoction of bala.)
(1) Medicine Name: shashtika shali , Reference: Charaka Samhita, Route: Topical, Dosage Form: Ksheerpaka, Dose: 2000(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka Samhita, Procedure details: Virechana karma was used as a Shodhana chikitsa in which Trivrit Avaleha using Draksha Phanta as anupana will be given. )
(1) Medicine Name: Trivrit Avaleha, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 70(g), Frequency: od, Duration: 1 Days
3Intervention ArmProcedure-dIpana , दीपन (Procedure Reference: Charaka Samhita, Procedure details: The patient will be given Deepana-pachana with Panchakola churna twice a day till samyaka Deepana pachana lakshana is obtained.)
(1) Medicine Name: Panchakola churna, Reference: Bhava Prakash Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 7 Days
4Intervention ArmProcedure-Patra Pinda svedana-karma, स्वेदन-कर्म (Procedure Reference: Arogyakalpadruma, Procedure details: •After completion of samsarjana krama ,Patra pinda sweda will be done using Vatahara Patra and Nirgundi taila.)
(1) Medicine Name: Nirgundi taila, Reference: Charaka Samhita, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 7 Days
5Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Charaka Samhita, Procedure details: •Then Snehapana with Kalyanaka ghrita will be given till Samyaka snigdha lakshana is obtained.)
(1) Medicine Name: Kalyanaka Ghrita, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Ghrita, Dose: 400(ml), Frequency: od, Duration: 7 Days
6Intervention ArmProcedure-pAcana, पाचन (Procedure Reference: Charaka Samhita, Procedure details: – The patient will be given Deepana-pachana with Panchakola churna twice a day till samyaka Deepana pachana lakshana is obtained.)
(1) Medicine Name: Panchakola churna, Reference: Bhava Prakash Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 7 Days
7Intervention ArmDrugClassical(1) Medicine Name: Balaarishta, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Arishta, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: NIL
(2) Medicine Name: Ashtavargam Kashayam, Reference: Sahasrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: NIL
(3) Medicine Name: Yograj Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: can be taken along with kashayam by dissolving in it
(4) Medicine Name: Ashwagandha Churna, Reference: Bhava Prakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: NIL
(5) Medicine Name: Vatagajankusha Rasa, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
8Intervention ArmProcedure-aBya~gga-karma, अभ्यंग-कर्म (Procedure Reference: Ashtanga Hridayam, Procedure details: Sarvanga abhyanga with Balaaswagandhadi taila will be done for 3 days (including day of virechana).)
(1) Medicine Name: Balaaswagandhadi taila, Reference: Sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 3 Days
9Intervention ArmProcedure-svedana-karma, स्वेदन-कर्म (Procedure Reference: Ashtanga Hridayam, Procedure details: Sarvanga Bashpa sweda with Dashamoola Kwatha will be done for 3 days (including day of virechana).))
(1) Medicine Name: Dashamoola kwatha, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 80(g), Frequency: od, Duration: 3 Days
10Intervention ArmProcedure-Shirodhara _mUrdhatailam/ Sirastailam, मूर्धतैलम्/ शिरस्तैलम् (Procedure Reference: Charaka Samhita, Procedure details: After completion of samsarjana krama Shirodhara using Ksheerabala Taila will be done.)
(1) Medicine Name: Ksheerabala taila, Reference: Ashtanga Hridayam, Route: Topical, Dosage Form: Taila, Dose: 3000(ml), Frequency: od, Duration: 7 Days
11Intervention ArmProcedure-talam, तलम् (Procedure Reference: Dharakalpah, Procedure details: In this procedure medicine is applied over the centre of the head with Rasnadi Churna and Ksheerabala 101 Taila.)
(1) Medicine Name: Rasnadi Churna, Reference: Sahasrayoga, Route: Topical, Dosage Form: Churna/ Powder, Dose: 8(g), Frequency: od, Duration: 7 Days
12Intervention ArmProcedure-yApana-bastiH, यापन-बस्तिः (Procedure Reference: Charaka Samhita, Procedure details: In this procedure the drugs are administered through anal canal and is retained for a certain period of time, drag the waste matters from all over the body into the colon and eliminates them out of the body resulting into the desired effect.)
(1) Medicine Name: Mustadi Yapana Basti, Reference: Charaka Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 740(ml), Frequency: od, Duration: 8 Days
13Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtanga Hridayam, Procedure details: In this procedure medicated oil will be administered through nose to eliminate the vitiated dosha using Ksheerabala 101 taila)
(1) Medicine Name: Ksheerabala 101 taila, Reference: Ashtanga Hridayam, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Duration: 16 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Patients who are fit to undergo Snehapana, Virechana, Swedana,Basti and Nasya Karma.
2.Diagnosed cases of Multiple Sclerosis with MRI , continuing allopathic medication and EDSS score less than 8.
3. ICD code: G - 35
4. Socio- economic status: All 
 
ExclusionCriteria 
Details  1. Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women, exposed skin related disease.
2.EDSS score more than 8 . 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in spasticity using MSSS 88 SCALE.

 		 (Day-0) (Day-22) (Day-38) (Day-52)

 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the change in Quality of life using MSQL54
instrument, Visual Analog score and EDSS.
 		 (Day-0) (Day-22) (Day-38) (Day-52)
 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   BACKGROUND:Multiple sclerosis (MS) is an autoimmune inflammatory disease in which fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination, scarring, and a broad spectrum of signs and symptoms.Myelin is a protecting and insulating sheath covering the nerves. MS affects the ability of nerve cells in the brain and spinal cord to communicate with each other. MS is a gradual process, which goes on for weeks, months, and years. The cause remains unknown to modern science. Theories include autoimmune, genetic, infectious, and environmental factors.Based on the immune basis of MS, some treatments and drugs have been discovered with different efficacies and indications for MS which mostly suppress the immune system so myelin sheath could be saved or the patient could experience a remission course. Unfortunately, there are some adverse effects (AE)associated with these drugs which can be considered mild or even severe.These AEs make MS treatment require a careful choice between these drugs by expert neurologists according to each patient’s situation and history. All these treatments are expensive and the prognosis is very poor Hence there is a need of cost-effective treatment, which help in reducing spasticity and improves the Quality of Life in the patients . The present study is formulated to find out the combined effect of Panchakarma procedures along with Shamana aushadhi.
OBJECTIVES OF THE RESEARCH:
PRIMARY:1) To determine the clinical efficacy of an ayurvedic treatment module in the management of Multiple Sclerosis for reducing Spasticity in patients of 21-55 years of age.
SECONDARY:1)      To improve the quality of life in patients with Multiple Sclerosis.
METHODOLOGY:
Sample size calculation: As no previous studies are available and it is a pilot study, the sample size will be limited to 15 only.
Sample Collection: - Patients attending the Panchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited
Total no. of days treatment given until (Shodhana) = 36 days
Total no. of days given Pratimarsha, Nasya, ShamanaAushadi = 16 days
Follow up = 90 days
Total Duration of Study = 142 days






 
Close