| CTRI Number |
CTRI/2023/07/055431 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Evaluation of herbal regimens in adults with acute/chronic pain and inflammation |
|
Scientific Title of Study
|
Clinical Study for the evaluation of Herbal regimens in Adults with Acute/chronic Pain and inflammation |
| 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 Sarvesh kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.113A, Department of Panchakarma,National Institute of Ayurveda, Jorawer singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.113A, Department of Panchakarma,National Institute of Ayurveda, Jorawer singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.113A, Department of Panchakarma,National Institute of Ayurveda, Jorawer singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVG life Sciences Limited |
|
|
Primary Sponsor
|
| Name |
BVG life Sciences Limited |
| Address |
Sagar Complex Nashik Phata Opposite Kasarwadi Railway Station Pune-411 034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sarvesh Kumar Singh |
National Institute of Ayurveda hospital |
Room no.113A,Department of Panchakarma,National institute of Ayurveda,Jaipur
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National institute of Ayurveda |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pain oil1, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Pain cream 1, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Til oil, Reference: Charak samhita, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Til oil cream, Reference: Ras tantra sara & bhaisajya kalpana, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pain oil 2, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: pain cream 2, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between 40 and 70 years of age.
2. Patients with the clinical features of OA of Knee joint.
3. Patients fit for Snehanaand Swedana.
4. Patients with radiological findings of Osteoarthritis based on grade 0 to 4 on Kellgren and Lawrence system of classification of Knee OA along with clinical features.
5. Chronicity less than 3 years.
|
|
| ExclusionCriteria |
| Details |
1) Patient, suffering from any chronic debilitating disease like T.B., D.M., Gout, Varicose veins, Asthma & other chronic problems etc. and having other serious pathology
2) Pregnant women and lactating mother
3) Associated with simple or compound fractures
4) Patients who have developed joint deformity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS (Visual Analogue Scale) for Pain |
baseline to 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Western Ontario & McMaster Universities Arthritis Index(WOMAC) score |
baseline to 28 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| Date of Study Completion (India) |
08/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
The present work is undertaken to assess the efficacy of herbal formulations in patients suffering from OA of the knee joint for 28 days maximum. The study population was 90 patients randomly divided into three equal groups of 30 individuals. 1. comparator arm – til oil and til oil-based cream (topical application) 2. Interventional arm 1- Pain oil -1 and Pain cream-1 3.-Interventional arm-2 Pain oil -2 and Pain cream-2 The oil formulations were tropically administered 1-2ml with 1-2g of cream (as per the surface area on painful Knee joint) twice a day. The primary outcome of the study was to analyze changes in VAS (Visual Analogue Scale) and the secondary outcome WOMAC Score was analyzed from Baseline to Week 4. |