| CTRI Number |
CTRI/2026/03/105123 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study to Assess the Pain-Relieving Effect of Two Ayurvedic Formulations in Elderly Patients with Knee Osteoarthritis |
|
Scientific Title of Study
|
A Randomized Single Blind Comparative Clinical trial to
Evaluate the Vedanasthapana effect of Shatyadi gritha over
Panchatikta Guggulu Gritha in Janusandhigata vata in Jara
With special reference to Osteoarthritis of knee in elderly |
| 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 Afreen Kashimasab Diddimani |
| Designation |
PG research scholar |
| Affiliation |
DGM ayurvedic medical college gadag |
| Address |
DGM ayurvedic medical college and hospital department of kayachikitsa OPD number 3
Gadag
Gadag
KARNATAKA
582102
India |
| Phone |
9380432068 |
| Fax |
|
| Email |
diddimaniafreen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yasmeen A Phaniband |
| Designation |
Professor |
| Affiliation |
DGM ayurvedic medical college gadag |
| Address |
DGM ayurvedic medical college and hospital department of kayachikitsa OPD number 3
Gadag
Gadag
KARNATAKA
582102
India |
| Phone |
9845515865 |
| Fax |
|
| Email |
yasmeenphaniband@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Afreen Kashimasab Diddimani |
| Designation |
PG research scholar |
| Affiliation |
DGM ayurvedic medical college gadag |
| Address |
DGM ayurvedic medical college and hospital department of kayachikitsa OPD number 3
Gadag
Gadag
KARNATAKA
582102
India |
| Phone |
9380432068 |
| Fax |
|
| Email |
diddimaniafreen@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Afreen kashimasab Diddimani |
| Address |
DGM ayurvedic medical college and hospital department of kayachikitsa opd no 3 Gadag582102 |
| 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 Afreen Kashimasab Diddimani |
D G M Ayurvedic medical college and hospital Gadag |
DGM Ayurvedic Medical college and Hospital
Dr SV Savadi road gadag
departement of kayachikitsa
opd no-03
Gadag
KARNATAKA |
9380432068
diddimaniafreen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DGM Ayurvedic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatyadi gritha, Reference: Gada nigraha prayoga khanda grithadikara , Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dugda), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Panchatikta guggulu gritha, Reference: Astanga hridaya chikitsa sthanavatavyadhi adhyaya , Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Dugda), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects with classical signs and symptoms of Janusandhigata vata
2 Subjects of aged between 60-80 years of either sex
3 Subjects willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Subjects suffering from Traumatic Infective Neoplastic Congenital disease of knee
joint and Rheumatoid arthritis Psoriatic arthritis
2 Subject suffering from any other systemic disorder like Cardiovascular disorder Renal
Disorder
3 Subjects suffering from Systematic lupus erythmatus
4 Uncontrolled Hypertension and Diabetes mellitus |
|
|
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 |
1 To know the reduction of classical signs and symptoms of Janusandhigata Vata in Jara.
2 Improved functional ability assessed by using WOMAC scale |
60 days treatment and 30 days follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Improvement of quality of life evaluated using SF-36 Questionnaires and Hemoglobin
(Hb%) red blood cells (RBC)
2 To assess safety and tolerability |
60 days treatment and 30 days follow-up |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/03/2026 |
| 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
|
Aging is a natural and inevitable biological process characterized by gradual degeneration of body tissues and physiological functions. In Ayurveda, this degenerative phase is termed Jara, which is considered a Swabhavika Vyadhi (natural condition of life). Disorders arising due to aging are referred to as Jarajanya Vyadhi. One such condition is Janusandhigata Vata, which clinically correlates with knee osteoarthritis in elderly individuals.
Janusandhigata Vata is described under Vatavyadhi in Ayurvedic classics and occurs when aggravated Vata dosha localizes in the knee joint, leading to symptoms such as joint pain (Sandhishoola), swelling (Shotha), stiffness, crepitus (Atopa), and painful flexion-extension movements (Prasarana–Akunchana Vedana). Degeneration of Asthi (bone tissue) and Shleshaka Kapha contributes to progressive joint deterioration.
Osteoarthritis is the second most common musculoskeletal disorder globally and predominantly affects older adults, especially women. It significantly impairs mobility, functional independence, and quality of life. Conventional management mainly includes NSAIDs and corticosteroids, which provide symptomatic relief but are associated with adverse effects such as gastritis, renal impairment, and cardiovascular risks during long-term use.
Shatyadi Ghrita, an Ayurvedic medicated ghee formulation indicated in Sandhigata Vyadhi, contains drugs possessing Vata-Kapha Shamaka, Shothaghna (anti-inflammatory), Vedanasthapana (analgesic), Deepana-Pachana (digestive stimulant), and Rasayana (rejuvenative) properties. Ghrita (ghee) itself is Vata-Pittashamaka, Balya, and Vayasthapaka, and enhances bioavailability of the incorporated drugs due to its Samskarasya Anuvartana property.
Panchatikta Guggulu Ghrita is a well-established formulation in the management of Sandhigata Vata and is considered a standard comparator.
The present study is planned to evaluate and compare the Vedanasthapana (pain-relieving) effect of Shatyadi Ghrita with Panchatikta Guggulu Ghrita in elderly patients suffering from Janusandhigata Vata (knee osteoarthritis), with an aim to assess safety, efficacy, and improvement in quality of life |