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CTRI Number  CTRI/2024/11/076665 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study the efficacy Of Gomutradi siddha Basti in the management of Amavata (Rheumatism due to ama) 
Scientific Title of Study   Randomized controlled clinical trial to study the efficacy of Gomutradi siddha basti in the management of Amavata (Rheumatism due to ama) 
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 Shubhangi Parmeshwar Thombare 
Designation  PG Scholar 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  9850738496  
Fax    
Email  shubhangithombare94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Dnyanoba Sonwane 
Designation  Associate Professor 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011  
Address  OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  9579773404  
Fax    
Email  ramesh10673@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shubhangi Parmeshwar Thombare 
Designation  PG Scholar  
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011

Aurangabad
MAHARASHTRA
431011
India 
Phone  9850738496  
Fax    
Email  shubhangithombare94@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
 
Primary Sponsor  
Name  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Address  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 
Type of Sponsor  Private 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 
Dr Shubhangi Parmeshwar Thombare  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001  OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra
Aurangabad
MAHARASHTRA 
9850738496

shubhangithombare94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AMAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Charak Samhita, Procedure details: Patient will be asked to lie down on droni (table) in vamaparshwa stithi i.e. left lateral position. 420 ml sukhoshna i.e. warm Gomutradi siddha basti will be taken in basti yantra for Niruha basti. 60 ml of warm Bruhatsaindhavadi taila will be taken for Anuvasan basti. Anus will be made lubricated with taila. Basti will be given by applying the appropriate pressure on basti putaka.)
(1) Medicine Name: Gomutradi Siddha Basti, Reference: Vangasen Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 420(ml), Frequency: od, Duration: 8 Days
2Comparator ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Charak samhita siddhi sthan, Procedure details: Patient will be asked to lie down on droni (table) in vamaparshwa stithi i.e. left lateral position. 420 ml sukhoshna i.e. warm Ardhamatrik basti will be taken in basti yantra for Niruha basti. 60 ml of warm Bruhatsaindhavadi taila will be taken for Anuvasan basti. Anus will be made lubricated with taila. Basti will be given by applying the appropriate pressure on basti putaka.))
(1) Medicine Name: Ardhamatrik basti, Reference: Chakrapanidatta, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 420(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting with signs & symptoms of Amavata mentioned in Ayurved classics.
Patients with seropositive seronegative results of RA factor.
Patients irrespective of their age, genders.
Basti Yogya Rugna. 
 
ExclusionCriteria 
Details  Basti Ayogya Rugna.
Rheumatoid Arthritis associated with -
Pregnancy
SLE
Any critical systemic diseases. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Sandhi shoola (pain in joints), Sandgi/Gatra stabdhata (morning stifness) will be reduced.  8 days 
 
Secondary Outcome  
Outcome  TimePoints 
Gaurava (heaviness), Aruchi (tastelessness), Sparshasahatva (tenderness in joints)  8 days 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   20/11/2024 
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="6"
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  
Amavata (Rheumatoid Arthritis) is a disease with variety of symptoms whose characteristic symptom is "persistent inflammatory synovitis" usually involving peripheral joints showing pain, swelling and tenderness. Where pain in affected joints gets aggravated by movement. The majority of patients experiences constitutional symptoms such as weakness, easy fatigability, anorexia & weight loss. For all such conditions, Ayurveda has described various Panchakarma procedures, out of which Basti chikitsa is advised mainly for Vatadosha pradhan vyadhis (diseases due to vitiated vatadosha). Overall taken drugs in this study being Deepana will improve Agni (digestive fire) which leads to absorption of Aama and also purifies vitiated vata dosha. Study will be conducted on 92 diagnosed patients of Amavata (Rheumatoid Arthritis). Written consent will be taken. Initial Assessment will be done. Patient will be treated with Interventional Group Gomutradi siddha basti and Control group Ardhamatrik basti. Patient will be assessed at follow up. Observation and result will be noted and statistical analysis, discussion and conclusion will be done.

Null Hypothesis (H0): Gomutradi Siddha basti is not effective in management of (Rheumatism due to Ama).

Alternate Hypothesis (H1): Gomutradi Siddha Basti is effective in the management of Amavata (Rheumatism due to Ama).
 
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