FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/075973 [Registered on: 28/10/2024] Trial Registered Prospectively
Last Modified On: 09/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on the role of Mahasneha and Dashmoola Ksheera Janu Basti in the management of Sandhivata (Osteo-Arthritis)  
Scientific Title of Study   A clinical study on the role of Mahasneha and Dashmoola Ksheera Janu Basti in the management of Sandhivata (Osteo-Arthritis)  
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 Shivani Paliwal  
Designation  PG Scholar 
Affiliation  Pt. Khushilal Sharma Ayurveda College and Institute, Bhopal MP 
Address  PG Department Of Panchakarma, Room No.111 Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal MP

Bhopal
MADHYA PRADESH
462007
India 
Phone  8982635330  
Fax    
Email  shivanipaliwal095@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamini Soni 
Designation  Associated Professor 
Affiliation  Pt. Khushilal Sharma Ayurveda College and Institute, Bhopal MP 
Address  PG Department Of Panchakarma, Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal MP

Bhopal
MADHYA PRADESH
462007
India 
Phone  8770037353  
Fax    
Email  skamini382@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivani Paliwal 
Designation  PG Scholar 
Affiliation  Pt. Khushilal Sharma Ayurveda College and Institute, Bhopal MP 
Address  PG Department Of Panchakarma, Room No.111 Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal MP

Bhopal
MADHYA PRADESH
462007
India 
Phone  08982635330  
Fax    
Email  shivanipaliwal095@gmail.com  
 
Source of Monetary or Material Support  
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal, MP India 462007 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP  
Address  PG Department Of Panchakarma, Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal MP India 462007 
Type of Sponsor  Government funding agency 
 
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 Shivani Paliwal  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Bhopal MP   PG Department Of Panchakarma, Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal MP
Bhopal
MADHYA PRADESH 		 08982635330

shivanipaliwal095@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Pt Khushilal Sharma Government Ayurveda Institute Bhopal(MP)  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
1Intervention ArmDrugClassical(1) Medicine Name: Mahasneha, Reference: Ashtang Hridayam of Vagbhatta , Ashtang Hridayam Chikitsa Sthan (21/28-29) edited by kaviraj Atridev Gupta Chaukhamba Sanskrit Sansthan Varansi Page No. 569, Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Principal and Practice of Panchkarma, Dr Vasant C. Patil, Chaukhamba Publication, New Delhi Page No. 171, Procedure details: 20 patients of this group will be treated with Dashmoola Ksheera Janu Basti for 30 min)
(1) Medicine Name: Dashmoola, Reference: Shrushut Samhita of Shrushut volume-1 Shrushut Samhita Sutra Sthan (38/67-72) edited by Dr Ambikadatt Shastri Chaukhamba Sanskrit Sansthan Varansi Page No. 188-89, Route: Topical, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Duration: 14 Days
3Comparator ArmProcedure-jAnu-bastiH, जानु-बस्तिः (Procedure Reference: Principal and Practice of Panchkarma, Dr Vasant C. Patil, Chaukhamba Publication, New Delhi Page No. 171, Procedure details: 20 patients of this group will be treated with Dashmoola Ksheera Janu Basti for 30 min)
(1) Medicine Name: Dashmoola, Reference: Shrushut Samhita of Shrushut volume-1 Shrushut Samhita Sutra Sthan (38/67-72) edited by Dr Ambikadatt Shastri Chaukhamba Sanskrit Sansthan Varansi Page No. 188-89, Route: Topical, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  1.Patients between the age group 35-64 years of either sex.
2.Patients having sign and symptoms of osteoarthritis as per diagnostic criteria.
3.Those who have given written consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Pregnant women and lactating mothers.
2.Severe Mental illness.
3.Traumatic arthritis , rheumatoid arthritis, psoriatic arthritis and gouty arthritis.
4.Patients who are known case of, any type of Malignancy, Chronic Renal failure, Rheumatic heart disease.
5.Acute illness like CVA, MI, Severe Hypertension and Hormonal imbalance like DM.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we would be able to demonstrate the effectiveness of Mahasneha Avapidaka Pana and Dashmoola Ksheera Janu Basti in the management of Sandhivata (OA)  12month 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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
Modification(s)  		 Phase 1/ Phase 2 
Date of First Enrollment (India)   15/03/2025 
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  

It is expected that at the end of the study we would be able to demonstrate the effectiveness  of  Mahasneha Avapidaka  Pana and Dashmoola  Ksheera Janu Basti  in the management of Sandhivata (OA). 

 
Close