| CTRI Number |
CTRI/2025/08/092323 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Pharmaco clinical study of effect of Ashwagandha Ghrita and Bala tail in knee osteoarthritis |
|
Scientific Title of Study
|
A Pharmaco clinical Study To Evaluate The Efficacy Of Ashwagandha Ghrita (Withania somnifera Linn) and Bala Tail(Sida cordifolia Linn) in Janu Sandhivata wsr to 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 |
Rahul Kumar |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G. Dept. of dravyaguna
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
P.G. Dept. of dravyaguna
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9773580188 |
| Fax |
|
| Email |
kumarrahul17698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof R B Yadav |
| Designation |
Professor and HOD |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G. Dept. of dravyaguna
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
P.G. Dept. of dravyaguna
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9412196868 |
| Fax |
|
| Email |
drrby67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof R B Yadav |
| Designation |
Professor and HOD |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P.G. Dept. of dravyaguna
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
P.G. Dept. of dravyaguna
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh
UTTAR PRADESH
226003
India |
| Phone |
9412196868 |
| Fax |
|
| Email |
drrby67@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital, Lucknow |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital, Lucknow |
| Address |
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh, India |
| Type of Sponsor |
Government 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 |
| Rahul Kumar |
State Ayurvedic College and Hospital, Lucknow |
State Ayurvedic College and Hospital, Lucknow 226003 Uttar Pradesh , India
Lucknow
UTTAR PRADESH |
9773580188
kumarrahul17698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional ethics Committee state ayurvedic college and hospital Lucknow Tulsidas marg, turiyaganj pincode- 226003 Uttar Pradesh |
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: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Ghrita, Reference: chakradatta Adhyaya 22/83, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Ghrita and Bala Tail, Reference: Chakradatt Adhyaya 22/83 and Chakradatt Adhyaya 22/93, Route: Oral, Dosage Form: Ghrita, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -Ashwagandha Ghrita will be given orally and Bala Tail will be appiled locally on the affected knee |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group between 40 to 70 years
2 The patients with classical signs and symptoms of sandhivata given in various texts as well as the clinical features of disease of OA given in Modern medicine
3 Patient who gave the consent to participate in study |
|
| ExclusionCriteria |
| Details |
1 Age group less than 30 years and more than 70 years
2 Patients having past history or actively suffering from other inflammatory disease like RA Gout Septic Arthritis etc
3 Cases with severe deformities of joint and having major complications are excluded
4 Pregnant and lactating women
5 Patients having substantial abnormalities in Hematological Hepatic Metabolic function and systemic disorders like Diabetes and Hypertension
6 Avaranjanya Sandhivata |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. pain in joints
2. crepitus
3. pain during extension and flexion
4. loss of motion and range
5. swelling in affected joint
6. morning stiffness(less than half an hour)
7. tenderness of joint |
- the follow up conducted during study period for once in 15 days.
After completion of trial of two month, the follow up without drug after 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. CBC, ESR
2. Blood sugar (HbA1c/random/fasting/pp)
3. CRP, Sr. Uric acid, RA factor
4. Lipid profile, LFT, KFT
5.X-Ray of the affected joint- AP/lateral view
6. S. Calcium, Vit. D3, thyroid profile, bone mineral density (if necessary) |
- the follow up conducted during study period for once in 15 days.
After completion of trial of two month, the follow up without drug after 15th day |
|
|
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 |
|
Date of First Enrollment (India)
|
22/08/2025 |
| 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 Yet Recruiting |
| 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
|
A OA patient experiences difficulty in persuing in day to day activity. therefore , i select this trial . this research evaluate the efficacy of ashwagandha ghrita & bala tail. this research is parallel group randomised clinical study of 60 patients. group A (n=30)- the patients will be given ashwagandha ghria (6gm) twice a day with lukewarm water after meal. group B(n=30)- the patients will be given bala tail for abhyang as local application(min 5 min) twice a day & ashwagandha ghrita(6gm) with lukewarm water twice a day after meal duration of trail - 2 months follow up - the follow up conducted during study period for once in 15 days. after completion of trial of 2 months , the follow up without drug after 15 days for one month. |