| CTRI Number |
CTRI/2019/09/021291 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs Ashwagandhadi Vati and Trayodashanga Guggulu in the Management of knee sandhivata with special reference to Degenerative Knee Arthritis |
|
Scientific Title of Study
|
A Comparative Study on Ashwagandhadi Vati & Trayodashanga Guggulu in the Management of Janusandhigatvata with special reference to Knee Osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anagha Kothadia |
| Designation |
M D Ayurved |
| Affiliation |
R A Podar Ayurved College |
| Address |
Department of Kayachikitsa
R A Podar Ayurved College,
Dr Annie Besant Road, Worli, Mumbai 400018
Dr Annie Besant Road Worli Mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9623960353 |
| Fax |
|
| Email |
drkothadiaclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta D Parulkar |
| Designation |
M D PhD Ayurved |
| Affiliation |
R A Podar Ayurved College |
| Address |
Department of Kayachikitsa, R A Podar Ayurved College,
Worli, Mumbai, 400018
Dr Annie Besant Road Worli Mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
08652694332 |
| Fax |
|
| Email |
geeta.parulkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anagha Kothadia |
| Designation |
M D Ayurved |
| Affiliation |
R A Podar Ayurved College |
| Address |
Department of Kayachikitsa,
R A Podar Ayurved College,
Worli, Mumbai, 400018
Dr Annie Besant Road Worli Mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9623960353 |
| Fax |
|
| Email |
drkothadiaclinic@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Podar Hospital(Ayu), Dr Annie Besant Road, Worli, Mumbai, Maharashtra 400018 |
| R A Podar Ayurved College, Dr Annie Besant Road, Worli, Mumbai, Maharashtra 400018 |
|
|
Primary Sponsor
|
| Name |
Dr Anagha Kothadia |
| Address |
SYURGA, 251/1, Plot 5/1, Sankalp Park Lane, Opp Aundh Telephone Exxchange, Aundh, Pune 41007 |
| Type of Sponsor |
Other [PhD Student ] |
|
|
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 Anagha Kothadia |
M A Podar Hospital, Department of Kayachikitsa |
Dr Annie Besant Road, Worli Mumbai 400018
Mumbai
MAHARASHTRA |
9623960353
drkothadiaclinic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, R A Podar Ayurved College, Dr Annie Besant Road, Worli Mumbai, Maharashtra 400018 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandhadi Vati |
The 42 patients of group one will be treated with oral administration of Ashwagandhadi vati 1 gm twice a day for 12 weeks and the another group of patients with Trayodashanga Guggulu of the same dose pattern with anupana of warm water. The therapeutic effects of the tablets will be assessed in respective groups based on specific subjective and objective parameters. The results will be obtained, compared and analyzed statistically in both the groups and the comparative efficacy will be assessed. |
| Comparator Agent |
Trayodashanga Guggulu |
A few clinical studies were conducted to prove efficacy of Trayodashanga Guggulu in Januvata. Evaluation of efficacy of Trayodashanga Guggulu was conducted in 2013 for the management of Manyasandhigatvata and was proved 50% effective, a comparative study of Trayodashang Guggulu in sandhigatvata was also conducted in comparison with diclofenac. It was proved that the Trayodashanga Guggulu was helpful in reducing pain and swelling. By considering very less side effects and contraindications of Trayodashanga Guggulu, it was advisable to use in sandhigatvata for a longer period too.
In this clinical trial 42 patients of group two will be treated with oral administration of Trayodashanga guggulu 1 gm twice a day for 12 weeks with anupana of warm water. The therapeutic effects of the tablets will be assessed in respective groups based on specific subjective and objective parameters. The results will be obtained, compared and analyzed statistically in both the groups |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male or Female of 30 to 70 years age group
Patients having signs & symptoms of Janusandhigatvata
|
|
| ExclusionCriteria |
| Details |
Patient with known history of rheumatoid arthritis, cancer, gout, uncontrolled hypertension, uncontrolled diabetes, unstable renal hepatic, cardiac disorder, paralysis.
Severe arthritis, bed ridden and unable to walk without assistance
Pregnant, lactating women
Patients with known contraindication to any ingredient of trial drug
Patients having infections of spine especially tuberculosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knee pain and knee function |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in symptoms other than knee pain and knee functions
Comparison between two drugs
Knee quality of life and overall health |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/11/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Clinical trial not yet completed and no data available for publication of this clinical trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised , parallel group, single center trial in which investigator is comparing efficacy of Ashwagandhadi vati and Trayodashanga guggulu in 84 patients for 3 months. This study will be conducted in M A Podar Hospital Worli Mumbai India. The primary outcome measures will be change in knee pain and knee functions. Secondary outcome measure will be change in other symptoms of janusandhigatvata, knee quality of life, overall health, sleep impairment, fatigue, work productivity, satisfaction with treatment.
|