| CTRI Number |
CTRI/2025/02/080447 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of shadanga Guggul in Janusandhigata vata |
|
Scientific Title of Study
|
Randomised open controlled clinical trial to evaluate the efficacy of Shadanga Guggul in Janusandhigata vata w s r to Osteoarthritis of knee joint |
| 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 Darshana Subhash Nawale |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7796371712 |
| Fax |
|
| Email |
nawaledarshana94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Parshuram Wagh |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshana Subhash Nawale |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7796371712 |
| Fax |
|
| Email |
nawaledarshana94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and
Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra 416114 India |
|
|
Primary Sponsor
|
| Name |
Dr Darshana Subhash Nawale |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
|
| Type of Sponsor |
Other [Self] |
|
|
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 Darshana Subhash Nawale |
Yashwant Dharmartha Rugnalay |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
7796371712
nawaledarshana94@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: JANUBEDAH (KEVALAVATA), (2) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: JANUBEDAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadanga guggul , Reference: Rasaratnasamucchay, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Consumption with pathya ahara vihara | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vatari Guggul, Reference: Rasaratnakar rasendrakhanda mantrakhanda, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Consumption with pathya ahara vihara |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Signs and symptoms of shoola Shotha akunchan prasaran samayi graha in unilateral or bilateral janu sandhigatavata.
Pain in affected joints more than 4 weeks
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
History of any surgical diagnostic intervention with reference to the affected joints
Janu Sandhigata aaghata (Trauma)
Patient who are incapacitated bedridden or confined to wheelchair
Patient with known case of gouty arthritis rheumatoid arthritis psoriatic arthritis malignancy
Patients having any deformity of knee hip or back
Patients on prolonged medication with corticosteroids anti depressant anticholinergics or any other drugs that may have an
influence on outcome of study
Alcoholics or drug abusers
Pregnant or lactating women
Patient who have completed participation in any other clinical trial during the past 6 months |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the efficacy of Shadanga guggul in Janu Sandhigata vata w s r to Osteoarthritis of knee joint assessing subjective parameters such as shoola Shotha akunchan prasaran samayi vedana |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Janusandhigata vata in detail from various ayurvedic texts
To study efficacy of shadanga guggul in signs of shoola shotha atopa akunchan prasaran janya Vedana in janu sandhigat vata
To study the effect of shadanga guggul in range of movement of knee
joint
To study the modern view of osteoarthritis of knee joint in detail
To achieve the outcome of study in 3 months |
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is an Randomised open controlled clinical trial to evaluate the efficacy of the Shadanga Guggul in Janusandhigata vata w s r to Osteoarthritis. The assesment of signs and symptoms will be done at regular follow ups. Observation will be drawn from the outcomes achieved in 90 days . |