FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/077093 [Registered on: 20/11/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Janu Sandhigata Vata with Rasanadya Churna orally and Trishatiprasarani tailam locally. 
Scientific Title of Study   Randomized open controlled clinical study to evaluate the efficacy of Rasanadya Churna Orally and Trishatiprasarani tailam locally in the management of Janu Sandhigata Vata w.s.r to Knee osteoarthritis in the age group of 35 to 70 years . 
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 Samiksha Ramesh Pakhare 
Designation  PG scholar. 
Affiliation  Dayabhai maoji majithiya Ayurved mahavidyalaya Yavatmal, Maharashtra 
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya Yavatmal affiliated with LK ayurved Rugnalaya Yavatmal Department of Kayachikista Ground floor Opd no 10 Yavatmal MAHARASHTRA 445001 India

Yavatmal
MAHARASHTRA
445001
India 
Phone  9011998402  
Fax    
Email  sameekshapakhare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh P Duddalwar 
Designation  Associate professor 
Affiliation  Department of Kayachikitsa, DMM ayurved Mahavidyalaya Yavatmal 
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya Yavatmal affiliated with LK ayurved Rugnalaya Yavatmal Department of Kayachikista Ground floor Opd no 10 Yavatmal MAHARASHTRA 445001 India

Yavatmal
MAHARASHTRA
445001
India 
Phone  9423624476  
Fax    
Email  dr.yogesh.duddalwar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Samiksha Ramesh Pakhare  
Designation  PG Scholar  
Affiliation  Dayabhai maoji majithiya Ayurved mahavidyalaya Yavatmal, Maharashtra 
Address  Dayabhai Maoji Majithiya Ayurved Mahavidyalaya Yavatmal affiliated with LK ayurved Rugnalaya Yavatmal Department of Kayachikista Ground floor Opd no 10 Yavatmal MAHARASHTRA 445001 India

Yavatmal
MAHARASHTRA
445001
India 
Phone  9011998402  
Fax    
Email  sameekshapakhare@gmail.com  
 
Source of Monetary or Material Support  
DMM ayurved Mahavidyalaya afiliated with L.K Ayurved rugnalaya Shivaji nagar Arni road yavatmal, 445001 
 
Primary Sponsor  
Name  DMM ayurved Mahavidyalaya Yavatmal 
Address  Department of Kayachikitsa, DMM ayurved Mahavidyalaya,shivaji nagar arni road Yavatmal, Dist-Yavatmal 445001, Maharashtra, India  
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 Yogesh P Duddalwar  DMM ayurved Mahavidyalaya And L. K Ayurved rugnalaya shivaji nagar Arni road Yavatmal  Opd no 10,Department of Kayachikista DMM Ayurved college yavatmal,Shivaji nagar, arni road, Yavatmal Yavatmal MAHARASHTRA
Yavatmal
MAHARASHTRA 		 9423624476

dr.yogesh.duddalwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee DMM ayurved Mahavidyalaya Yavatmal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Rasanadya Churna, Reference: Gadnighrah, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ghrita and koshnajal ), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Trishatiprasarani tailam, Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: Dashmool Churna, Reference: Sushrut Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ghrita and koshnajal ), Additional Information: -
4Comparator ArmDrugClassical(1) Medicine Name: Mahanarayan tailam, Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age group between 35 to 70 years.
2.Patient having sign and symptoms of Janu Sandhigata Vata according to classics.
a)Sandhi shoola (joints pain)
b)Sandhi shoth (joints swelling)
c)Vatapurnadrutisparsh(joints Crepitus )
b) Prasarana Aakunchana vedana(pain in flexion and extension of joints)
3.Patient willing and able to participate in the study, irrespective of any gender,
occupation, religion, economic status.
4.Radiological degenerative changes in knee joints.
5. Patients who are ready to switch over to ayurved Medicine.
6. Patients who will fulfill the criteria and take regular medicines with regular follow up. 
 
ExclusionCriteria 
Details  1) Patients with fracture of Knee Joint will be excluded from the study.
2) Patients with Rheumatoid Arthritis, Rheumatic fever, Rheumatic Heart Disease, Gouty
Arthritis and Infective Arthritis, Koch’s disease.
3) Age group below 35 yrs and above 70 yrs.
4) Patient having disease like Diabetes Mellitus and Chronic Kidney Disorder.
5) Pregnant ladies and lactating mothers.
6) Malignancy . 
 
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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In present clinical trial, the patients was
diagnosed on the basis of signs and symptoms
describe in ayurvedic text
i.e subjective criteria
a)Sandhi shoola (joints pain) b)Sandhi shoth (joints swelling) c)Vatapurnadrutisparsh(joints Crepitus ) b) Prasarana Aakunchana vedana(pain in flexion and extension of joints)  		 0,8th,15th,22nd,29th,36th,45th,60th,75th,90th day 
 
Secondary Outcome  
Outcome  TimePoints 
1 WOMAC Scale
2 VAS scale
1.CBC 2.ESR 3. BSL 4.X RAY
5. R A Factor
Above investigation & other required investigation will be carried out to rule out serious illness if any & whenever they are necessary.
 		 0,8th,15th,22nd,29th,36th,45th,60th,75th,90thday 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   26/12/2024 
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   Due to continuous changes in life style over exertion , improper diatery habits, excessive travelling, improper working as well as improper application of Dinacharya (Daily Regimen) and RituCharya (seasonal Regimen) and likewise other factor leads to vitation of vatadosha. This vitation of vata dosha leads to production of number of disease and Sandhigata vata is one of them .The word "Gata’ in sandhigatavata denotes an initation of movement carrying something along with or to reach a particular site through any particular pathway, that leads to occupancy of that particular site. The presentation of this pathogenesis is seen as Janu Sandhigata Vata. Being most weight bearing joints the knees commonly get affected,presenting symptioms like Sandhi Shoola (joints pain) ,Sandhi Shotha (joints swelling), Vatapurnadrutisparsh(joints crepitus) , Prasaran Aakunchan vedana (pain in flexion and extension of joints). 
Close