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CTRI Number  CTRI/2022/05/042676 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 09/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “An study to evaluate the efficacy of virechana(purgation) and basti (enema) followed by vishwadi dwadashanga kwatha (decoction) in the management of fibromyalgia”. 
Scientific Title of Study   “An open comparative clinical study to evaluate the efficacy of virechana karma and basti followed by vishwadi dwadashanga kwatha in the management of mamsagata vata w.s.r to fibromyalgia”. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopesh Mangal  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda  
Address  PG department of Panchakarma National Institute of Ayurveda Amer Road,Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011   
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gopesh Mangal  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda  
Address  PG department of Panchakarma National Institute of Ayurveda Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011   
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr SHALU RANI SINGHAL 
Designation  M.D.Scholar 
Affiliation  National Institute of Ayurveda  
Address  PG department of Panchakarma National Institute of Ayurveda Amer Road Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  6378766221  
Fax    
Email  shalusinghal147@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda  
 
Primary Sponsor  
Name  National Institute of Ayurveda  
Address  Madhav Villas Palace Amer Road Jaipur Rajasthan India  
Type of Sponsor  Government medical college 
 
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 
Shalu Rani Singhal  National Institute of Ayurveda   Opd room no 2 and IPD, PG department of Panchakarma,National Institute of Ayurveda Jaipur RAJASTHAN
Jaipur
RAJASTHAN 		 6378766221

shalusinghal147@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M628||Other specified disorders of muscle. Ayurveda Condition: MAMSAGATAVATAKOPA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: (Procedure Reference: charak chikitsha 28/93, , Procedure details: Time of administration of Virechana Karma – Late morning, once As per SOP of P.K. Dept. NIA Jaipur.) )
(1) Medicine Name: Viswadi Dwadashangaa Kwatha ,, Reference: Bharat Bhaishjya Ratnakar Yog no.6543,, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(g), Frequency: bd, Duration: 15 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: (Ch. sidd. 3/61-64), Procedure details: Time of administration of Basti – Early noon, Once day (As per SOP of P.K. Dept. NIA Jaipur). Treatment period – 16 days ))
(1) Medicine Name: Viswadi Dwadashangaa Kwatha, Reference: Bharat Bhaishjya Ratnakar Yog no.6543,, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(g), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients between 18 and 65 years of age.
2. Patients with the clinical features of Mamsagata Vata.
3. Patients with the clinical features of Fibromyalgia.
4. Patients fit for Virechana Karma and Niruha Basti.
5. Chronicity less than 10 years.
 
 
ExclusionCriteria 
Details  1. Patient, suffering from any chronic debilitating disease like T.B., Varicose vein, Asthma, Rheumatoid Arthritis & other chronic problems etc. and having other serious pathology.
2. Patients suffering from systemic disorders as cardiac problem, uncontrolled Diabetes Mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, HIV, HBsAg, Leprosy.
3. Pregnant women and lactating mother.
4. Associated with simple or compound fractures.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in American College of Rheumatology (ACR): Preliminary Criteria for Fibromyalgia   assessment will be done on 0thday, 16th day, 31st day. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ).
2. VAS-SCALE.: VAS have been recommended: no pain (0–4 mm), mild pain (5-44 mm),
moderate pain (45–74 mm), and severe pain (75–100 mm)
 		 assessment will be done on 0thday, 16th day, 31st day. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Fibromyalgia syndrome (FMS) is defined as a chronic pain syndrome with a complex, multifactorial and not completely known etiopathogenesis and an increased frequency among women.It is characterized by generalized musculoskeletal pain and palpation specific tender points on physical examination often accompanied by associated symptoms such as sleep disorders, fatigue, somatic and cognitive symptoms, as well as psychic disorders.The first ever description of the disease multiple and widespread pain in muscles ultimately fatigue in Ayurveda text was mentioned as Mamsagata Vata. The specific disease condition associated with ‘Gurvang, atyarth todanvat vedana, Dandmushtihatam vedana, tatha atyarth sharmita- (Multiple and widespread pain in muscles ultimately fatigue, palpation specific tender points accompanied with associate symptom such as sleep disorders, somatic and cognitive symptoms as well as psychic disorders). The textual line of treatment of Vatavyadhi is followed in the treatment of Mamsagata Vata which states Virechana, Niruha Basti and Shaman Chikitsa.In this work Virechana, Rasnadi Basti and Vishwadi Dwadashanga Kwatha are purposed as an adjuvant therapy in the management of Mamsagata Vata with special reference to Fibromyalgia.

WORK PLAN:

GROUPING

Patients will be randomly divided into two groups (15 patients in each group) detail as below-

Group A – Virechana Karma followed by Viswadi Dwadashanga Kwatha.

Group B – Rasnadi Basti followed by Viswadi Dwadashanga Kwatha

Route and method of application –

1.         Virechana will be conducted as per standard protocol and Virechana Yoga will be given according to Koshtha on empty stomach at 9-10 am.

2.         Rasnadi Basti in Kala Basti Krama (for 16 days) through anal route.

3.         Viswadi Dwadashanga Kwatha as Shamana Chikitsa for 15 days.

Time of administration of Virechana Karma – Late morning, once (As per SOP of P.K. Dept. NIA Jaipur).

Route and method of administration of Virechana Karma –

1.      Snehpana –It will be done by Go-Grhita for 3days.

2.     Sarvanga Abhyanga (with Dashmoola taila) Sarvanga Swedana (with Dashmoola Kwatha) for continue 4 days.

3.     Virechana will be conducted as per standard protocol and Virechana Yoga will be given through Oral route according to Koshtha on empty stomach at 9-10 am.

4.     Sansarjana Krama - According to Shuddhi

Method of administration of Viswadi Dwadashanga Kwatha- Oral route

Dosage for Viswadi Dwadashanga Kwatha – 20 gm B.D. (Morning and Evening) Before Meal.



 
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