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CTRI Number  CTRI/2023/01/049150 [Registered on: 23/01/2023] Trial Registered Prospectively
Last Modified On: 21/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the efficacy of Shatavhvadi taila Matrabasti in Janu Sandhigata vata w.s.r. to Osteoarthritis.  
Scientific Title of Study   Randomized controlled clinical study of Shatavhadi taila Matrabasti in Janu Sandhigata vata w.s.r. to Osteoarthritis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarika Prashant Chavan 
Designation  First Year PG Scholar (Panchakarma department)  
Affiliation  Yashwant Ayurvedic College and Hospital Kodoli 
Address  Ground Floor of Panchakarma dept. OPD of Panchakarma dept. Yashwant Ayurvedic College and Hospital Kodoli, Tal-Panhala Dist-Kolhapur Maharashtra India.

Kolhapur
MAHARASHTRA
416114
India 
Phone  9284316467  
Fax    
Email  drpjc22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidyanand K Thorwat 
Designation  Professor (Panchakarma Department) 
Affiliation  Yashwant Ayurvedic College and Hospital Kodoli. 
Address  Panchakarma dept. Second floor Panchakarma OPD ground floor, Yashwant Ayurvedic College and Hospital Kodoli, Tal-Panhala Dist-Kolhapur.

Kolhapur
MAHARASHTRA
416114
India 
Phone  9011081819  
Fax    
Email  vidyanandthorwat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarika Prashant Chavan 
Designation  First Year PG Scholar (Panchakarma department)  
Affiliation  Yashwant Ayurvedic College and Hospital Kodoli. 
Address  Yashwant Ayurvedic College and Hospital Kodoli, Tal-Panhala Dist-Kolhapur 416114 Maharashtra India.

Kolhapur
MAHARASHTRA
416114
India 
Phone  9284316467  
Fax    
Email  drpjc22@gmail.com  
 
Source of Monetary or Material Support  
Yashwant Ayurvedic College and Hospital Kodoli. Kolhapur. 
 
Primary Sponsor  
Name  Dr Sarika Prashant Chavan 
Address  Yashwant Ayurvedic College And Hospital, Kodoli Kolhapur 
Type of Sponsor  Other [Self] 
 
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 Sarika Prashant Chavan  Yashwant Ayurvedic College And Hospital Kodoli  Prakriti Panchakarma and Wellness Center Yashwant Ayurvedic College And Hospital Kodoli Tal-Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA 		 9284316467

drpjc22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Yashawant Ayurvedic College And Hospital Kodoli   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Astang Hriday 19/68, Procedure details: Ksheerabala Taila Matrabasti- Matrabsti with ksheerabala tala with 70 ml quantity is given after proper purvakarma into anal canal by following ideal method. it is given for 9 days daily.)
(1) Medicine Name: Ksheerabala taila, Reference: Sahstrayogam Taila prakaran, Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 9 Days
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Astang Hriday 19/68, Procedure details: Shtavhadi taila Matrabasti- Purvakarma- Patient is asked to take light diet. he is subjected for abhyanga and swedana. Pradhankarma- He is asked to take left lateral position. Anal region is cleaned. 1pala ( 70ml) warm Shatavhadi taila is loaded in disposable syringe. Rubber catheter is fixed to the syringe nozzle. it gently inserted into anal canal. Catheter is removed. Sterile gauge is kept at place. Paschatkarma- After observing he is advised to take hot water bath. Pathyapatya is advis)
(1) Medicine Name: Shatavhadi taila, Reference: Charaka Siddhisthana 4/7,8, Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with clinical signs and symptoms of Niram avastha Janusandhigata vata ( osteoarthritis of knee)
2. Patients with pratyatma lakshana of Sandhigata vata
3. Age group 40 to 70 years irrespective of sex, religion and socioeconomic status.
4. Patients who are fit for Matrabasti and are willing to sign the informed consent will only be included in the study. 
 
ExclusionCriteria 
Details  1. Patients having systemic disorder which might interfere with the treatment.
2. Patients who are not fit for Matrabasti.
3. Patients with infective Neoplastic and traumatic condition of Knee joint. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in Ruk( pain), Stambha(stiffness), Sandhisphutan(crepitus),
Sandhishoth(Swelling). Reduction in the values of
Visual Analogue scale for pain
And Ritchie Articular Index for tenderness. 		 5 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Further Improvement in Ruk( pain), Stambha(stiffness), Sandhisphutan(crepitus), Sandhishoth(Swelling). Reduction in the grades of Visual Analogue Scale that assesses pain reduction . Reduction in the grades of Ritchie Articular index for Tenderness.  21 days. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   26/01/2023 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Patients of Sandhigata vata( Osteoarthritis) are having Sandhishula, akunchna prasaranayoh vedana( Knee pain), Sandhigraha( stiffness), Sandhisphutana ( Crepitus)Sandhishotha ( swelling) in knee joint. Matrabasti is an important treatment  mentioned in Samhitas for patients with above symptoms.. Shatavhadi taila is mentioned as best medicine for Matrabsti in Charaka Samhita that treats Vata, Hence this treatment is advised to improve the symptoms of Sandhigata vata. 
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