| CTRI Number |
CTRI/2024/09/074376 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Multimodal Ayurvedic Management of Primary Osteoarthritis of Knee |
|
Scientific Title of Study
|
A Multimodal Ayurvedic Intervention In The Management Of Primary Osteoarthritis Of Knee - A Single Arm Clinical Study. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Sureshbhai Prajapati |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121
Anand
GUJARAT
388121
India |
| Phone |
9537117686 |
| Fax |
|
| Email |
kp129600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manchak Kendre |
| Designation |
Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121
Anand
GUJARAT
388121
India |
| Phone |
9429200112 |
| Fax |
|
| Email |
manchak.kendre@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Sureshbhai Prajapati |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121
Anand
GUJARAT
388121
India |
| Phone |
9537117686 |
| Fax |
|
| Email |
kp129600@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388121 |
|
|
Primary Sponsor
|
| Name |
Dr. Komal Sureshbhai Prajapati |
| Address |
Department of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388121 |
| 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 Komal Sureshbhai Prajapati |
S. G. Patel Ayurveda Hospital and Maternity Home |
Department of Kayachikitsa, OPD No. 14, New Vallabh Vidyanagar, Anand, Gujarat, India- 388121
Anand
GUJARAT |
9537117686
kp129600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J Patel Institute Of Ayurvedic Studies And Research & S.G. Patel Ayurveda Hospital & Maternity Home Institutional Ethics Committee |
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: Hingwastak churna, Reference: Bhaishajya ratnavali 10/59, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Goghrita ), Additional Information: Deepan Pachan- Hingwastak churna for 3 days (2) Medicine Name: Ashwagandha ghrita, Reference: Bhaishajya ratnavali 26/220, Route: Oral, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: Snehapana -Ashwagandha ghrita In incremental dose (60ml-80ml-100ml-120ml-140ml) In morning empty stomach For 5 days(3) Medicine Name: Nirgundi taila, Reference: Charak Chikitsa 28/134-135, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: Abhyanga Swedana -Nirgundi ta |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with classical signs & symptoms of Primary Osteoarthritis of knee.
2) Patient having Nirupstambhi Sandhigatavata Lakshana.
3) Patient’s grade 1 to 3 according Kellgren-Lawrence grading scale will be taken for study.
4) Snehapana, Asthapana and Anuvasana Basti yogya patient.
5) Patients willing to participate in clinical trial. |
|
| ExclusionCriteria |
| Details |
1) Patient having Upstambhi Sandhigatavata Lakshana.
2) Patients grade 4 according Kellgren-Lawrence grading scale will be excluded for the study.
3) Snehapana, Asthapana and Anuvasana Basti ayogya patient.
4) Patients with uncontrolled Diabetes mellitus and Hypertension, known case of Heart disease, Kidney disease, Stroke, Liver disease, Pulmonary dysfunction or COPD systemic illness like Rheumatoid arthritis, Gout, Systemic lupus erythematosus, Tuberculosis, AIDS and SIDS etc. which interferes the clinical trial.
5) Patients taking medications like NSAIDs, Corticosteroids, Hormonal therapy, Anti depressants or any other drugs which may affect outcome of the study.
6) Patients with alcohol and tobacco addiction or drug abuse. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Pain in knee joint, Swelling on knee joint, Stiffness, Pain during flexion and extension, Crepitus, Degenerative changes of Primary osteoarthritis. |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in life quality of patient. |
Within 3 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Primary Osteoarthritis is most common joint degenerative disease restricting day to day activity of patients due to pain. Treatment provides only symptomatic relief that is for limited duration. This study includes the treatment method from classical Ayurvedic texts. Who are suffering from cardinal and associated symptoms of Primary osteoarthritis satisfying the inclusion & exclusion criteria are selected for the study. The selected subjects are given Hingwastak Churna 5 gm twice a day First morsel of meals with Goghrita for 3 days, followed by incremental administration of Ashwagandha ghrita for 5/7 days(60ml-80ml-100ml-120ml-140ml). After getting Samyaka Snigdha lakshana, Abhyang and Swedana are performed using Nirgundi taila and Baspa sweda, respectively for 8 days and Yoga Basti conducted with Anuvasana basti with Ashwagandha ghrita 120ml/dose and Niruhbasti with Erandmooladi niruh Madhu-160 ml, Lavana-12 gm, Sneha-240 ml, Kalka-80 gm, Kwath-320 ml, Gomutra-160 ml dose adjust according to patient. As per Shuddhi Samsarjan krama provided. Then Rasayana chikitsa with Ashwagandha churna10gm in morning with Godugdha and Triphala churna 10gm at night with warm water is given for 2 month. Total duration of study is 3 months. |