| CTRI Number |
CTRI/2025/02/081193 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Tryushnadi Guggul and Rasnadi Guggul in Managing Knee Osteoarthritis (Janu Sandhigata Vata) |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL TRIAL OF EFFICACY OF TRYUSHNADI
GUGGUL AND RASNADI GUGGUL IN MANAGEMENT OF JANU
SANDHIGAT VATA W.S.R. KNEE OSTEOARTHRITIS
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shital Himatrao Tayade |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa Department OPD No. 6 Front of prasad hotel, pune-nashik highway, Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7447333531 |
| Fax |
|
| Email |
tayadeshitu99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pathan Md Junaid |
| Designation |
Associate Professor |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa Department OPD No. 6 Front of prasad hotel, pune-nashik highway, Sangamner
MAHARASHTRA
422605
India |
| Phone |
7709483864 |
| Fax |
|
| Email |
junaidklm86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Shital Himatrao Tayade |
| Designation |
PG SCHOLAR |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa Department OPD No. 6 Front of prasad hotel, pune-nashik highway, Sangamner
MAHARASHTRA
422605
India |
| Phone |
7447333531 |
| Fax |
|
| Email |
tayadeshitu99@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SST Ayurved Mahavidyalaya Sangamner |
| Address |
SST Ayurved Mahavidyalaya, Kayachikitsa Department OPD No. 6 Front of prasad hotel, pune-nashik highway, Sangamner Pincode 422605, Maharashtra |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shital Himatrao Tayade |
SST Ayurved Mahavidyalaya, Sangamner |
SST Ayurved Mahavidyalaya, Kayachikitsa Department OPD No. 6 Front of prasad hotel, pune-nashik highway, Sangamner
Ahmadnagar
MAHARASHTRA |
7447333531
tayadeshitu99@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M899||Disorder of bone, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadi guggul, Reference: yogaratnakar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tryushnadi guggul, Reference: rasaratna, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. age group 40 to 65 years
2. pt having symptoms of janu sandhishool, janu sandhi shotha, sparshasahatva, janusandhi sputhan
3. pt will be selected irrespective of sex and socioeconomic status |
|
| ExclusionCriteria |
| Details |
1. k/c/o - amavata
2. k/c/o - gout
3. with H/o TB, malignancy, HIV, trauma
4. cardiac diseases, neurologic disorders
5. pregnant and lactating women
6. pt with total knee joint replacement
7. k/c/o - DM, HTN |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of tryushnadi guggul and rasanadi guggul in management of janu sandhigat |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to relief janu sandhigat vata |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/03/2025 |
| 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="6"
Days="1" |
|
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 comparative clinical evaluation of the efficacy of tryushnadi guggul and rasnadi guggul in the management of janu sandhigata vata with age group of 40 to 65 years both male and females included 35 patient in each group trial and control |