| CTRI Number |
CTRI/2024/04/065463 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Knee Osteoarthritis with the help of Ayurvedic Medicine |
|
Scientific Title of Study
|
A Clinical Study to Compare the Efficacy of AsthiśṛṃkhalÄ Ghá¹›ta and AÅ›vagandhÄ CÅ«rṇa with AtibalÄmÅ«la KvÄtha in the
patients of JÄnu SandhigatavÄta (Knee Osteo Arthritis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Gopiben Ghanashyambhai |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kayachikitsa
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital
College Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7567561410 |
| Fax |
|
| Email |
gopipatel9699@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dhaval M Dholakiya |
| Designation |
Professor |
| Affiliation |
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kayachikitsa
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital
College Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8980925520 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Dhaval M Dholakiya |
| Designation |
Professor |
| Affiliation |
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital |
| Address |
Department of Kayachikitsa
J S Ayurveda Mahavidhyalaya and P D Patel Ayurveda Hospital
College Road
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8980925520 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda Pharmacy
J S Ayurveda Mahavidhyalaya |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidhyalay |
| Address |
J S Ayurveda Mahavidhyalay
College Road
Nadiad 387001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| J S Ayurveda Mahavidhyalaya |
J S Ayurvda Mahavidhyalaya
College Road
Nadiad 387001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gopiben Ghanashyambhai Patel |
P D Patel Ayurveda Hospital |
Department of Kayachikitsa
OPD
Room NO 101 and 102
NADIAD 387001
Kheda
GUJARAT |
7567561410
gopipatel9699@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC For Human Research MAM University Nadiad |
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 churna, Reference: Database on medical plants used in Ayurveda, Ashwagandha, volume 3, page 88, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: -(2) Medicine Name: Atibalamula Kwatha, Reference: Database on medicinal plants used in Ayurveda, Atibala, volume 1, page 50, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asthishrinkhala ghrita, Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients fulfilling the ayurvedic as well as modern criteria of diagnosis of OA.
2)Patient with signs and symptoms of knee joint osteoarthritis.
3)Patients without any previous anatomical deformity.
|
|
| ExclusionCriteria |
| Details |
1)Female patients having pregnancy or lactating period.
2)Patient with associated disease which affects the outcomes or completion of the treatment i.e., cardiovascular disorders, osteoporosis, hyperthyroidism or hypothyroidism, obesity (BMI≥30), cancer, tuberculosis, rheumatoid arthritis, psoriatic arthritis, gout, kidney and liver disorders.
3)Patients having past traumatic history and complete loss of articular cartilage.
4)Patients who have history of previously joint transplantation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effect of asthishrinkhala ghrit in compare to aswagandha churna with atibalamool kwatha by observing the changes in VAS for pain and WOMAC SCALE in the patient of janu sandhigatavata (Knee osteoarthritis) |
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To find out the changes of signs and symptoms in both groups of the patients of janu sandhigatavata.
2)To find out the changes in X-ray after taking of asthishrinkhala ghrita and aswagandha curna with atibalamool kwatha in the patients of janu sandhigatavata (Knee osteoarthritis)
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2024 |
| Date of Study Completion (India) |
24/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
This will be submitted in form of dissertation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sandhigatavata occurs when vata lodges in sandhi. we can correlate janu sandhigatavat with knee osteoarthritis on the basis of clinical features. OA is defined as chronic joint disorder with detoriation of articular cartilage and bone at joint margin called osteophytes and capsular fibrosis. 30 patients who fullfill the inclusion criteria were selected through computer generated randomization method and allocated in two groups. one group was treated with asthishrinkhala ghrita and another group treated with aswagandha churna with atibalamool kwatha for 4 weeks and assessed the before and after treatment. However, the comparison between groups using unpaired t-tests
indicated no significant difference in efficacy. Both asthishrinkhala ghrita and ashvagandha churna with atiabalamoola kwatha proved effective in Sandhigatavata patients, with no observable
superiority of one over the other. |