| CTRI Number |
CTRI/2024/11/076197 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate the combined effects of Vishatindukadi vati and Amritadi guggulu in Janusandhigata vata (Osteoarthritis of knee joint) |
|
Scientific Title of Study
|
A Randomised Clinical Study to Evaluate Combined Effect of Vishatindukadi vati and Amritadi guggulu in Janu sandhigata vata (Osteoarthritis of Knee Joint) |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Rathod |
| Designation |
PG scholar |
| Affiliation |
Muniyal institute of Ayurveda medical sciences Manipal |
| Address |
Muniyal institute of ayurveda medical sciences manipal
34 C shivalli industrial area manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8147867692 |
| Fax |
|
| Email |
priyankarathod557@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shripathi Acharya G |
| Designation |
Professor |
| Affiliation |
Muniyal institute of ayurveda medical sciences Manipal |
| Address |
Muniyal institute of ayurveda medical sciences manipal
34 C Shivalli industrial area Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845387720 |
| Fax |
|
| Email |
shripathi_acharya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Rathod |
| Designation |
PG scholar |
| Affiliation |
Muniyal institute of ayurveda medical sciences Manipal |
| Address |
Muniyal institute of ayurveda medical sciences Manipal
34 C Shivani industrial area Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8147867692 |
| Fax |
|
| Email |
priyankarathod557@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muniyal institute of ayurveda medical sciences, shivalli industrial area, manipal, Udupi 576104 |
|
|
Primary Sponsor
|
| Name |
Muniyal institute of ayurveda medical sciences Manipal |
| Address |
Muniyal institute of ayurveda medical sciences Manipal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka Rathod |
Muniyal institute of ayurveda medical sciences Manipal |
KC opd Room No 4 Ground floor
34C Shivalli industrial area manipal
Udupi
KARNATAKA |
8147867692
priyankarathod557@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muniyal institute of ayurveda institutional ethical 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: Amritadi guggulu & vishatinduka vati, Reference: Bhava Prakasha & Rasatantrasara and Sidha prayoga sanghraha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Swangasheeta jala ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga guggulu, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: swangasheeta jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 30-70 years of age irrespective of gender & socio economic state.
|
|
| ExclusionCriteria |
| Details |
1. Janu Sandhigata Vata associated with other disease secondary to diabetes, IHD, CHF etc.
2. During pregnancy and lactation period.
3. H/o of trauma and bony deformity of knee joint.
4. Those who are under treatment with corticosteroids.
5. Patients with history of asthma, peptic ulcer and other complicated diseases.
6. Patient with Gouty arthritis rheumatoid arthritis, tubercular arthritis supuritive |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in swelling and pain |
Expected by 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in range of motion |
Improvement expected by 1 month |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/11/2024 |
| 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="2"
Days="9" |
|
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
|
Sandhigata vata (Osteoarthritis) is a most common disease affecting 4% of world population. Regrettably treatment options are few and mainly managed with Analgesics and in severe case surgeries are recommended. As to explore the efficacy of ayurvedic formulation, a classical yoga namely Vishatindukadi Vati has been selected for this present study along with Amritadi Guggulu. Total 40 Patients will be selected as per the inclusion exclusion criteria and will be grouped into two ie Group A and Group B. Patients in group A (Study group) will be administered Amritadi Guggulu 500mg thrice a day and Vishatindukadi vati 60 mg thrice a day with Swangasheeta Jala for a duration of 30 days along with pathya ahara and vihara. Patients in group B are also placing with same pathya ahara and vihara as of group A and will be treated with a controlled drug Trayodashanga Guggulu in a dose of 500mg thrice a day. Total study duration will be 45days and assessments will be done on 0th, 15th, 30th and 45th day.
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