| CTRI Number |
CTRI/2020/11/029039 [Registered on: 11/11/2020] Trial Registered Prospectively |
| Last Modified On: |
28/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study conducted to see the effect of Vasadi Kwath with Erand Tail in symptoms of Vatarakta |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF VASADI KWATH AND ERAND TAIL IN VATARAKTA(GOUT). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sima Balaprasad Jaju |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
Kayachikitsa Opd no 5 and IPD Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9096563058 |
| Fax |
|
| Email |
simajaju04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digambar Dipankar |
| Designation |
Prof. MD Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
drdgdipankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sima Balaprasad Jaju |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Centre Pimpri Pune |
| Address |
Kayachikitsa OPD No.5 and IPD Dr D Y Patil College Of Ayurveda And Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9096563058 |
| Fax |
|
| Email |
simajaju04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of ayurved And Research Centre |
|
|
Primary Sponsor
|
| Name |
Sima Balaprasad Jaju |
| Address |
Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune |
| Type of Sponsor |
Other [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 |
| Sima Jaju |
Dr D Y Patil College Of Ayurved And research Centre Pimpri Pune |
Kayachikitsa OPD And IPD Dr D Y Patil College Of Ayurved And research Centre Sant tukaram Nagar Pimpri Pune
Maharashtra
Pune
MAHARASHTRA |
9096563058
simajaju04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, (3) ICD-10 Condition: M20-M25||Other joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Vasadi Kwath(40ml) along with Erand Tail (5ml) orally Twice daily |
Vasa,Aragvadha,Guduchi Each churna 5gm boiled with 160ml water reduced to 40ml. patient will be asked to sieve it and consumed orally after it is cooled down along with 5ml Erand Tail. This will be advised to take twice a day for the period of 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age limit from 20 to 70 years.
Patients having clinical symptoms of Vatarakta like Pain in joints, Swelling, burning, Tenderness at joints.
|
|
| ExclusionCriteria |
| Details |
Patient with severe form of other systemic disorders like Cardiac disease, renal failure, CVA etc will be excluded.
Pregnant women and lactating mothers.
Injury requiring surgical interventions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To achieve marked relief in signs and symptoms of vatarakta |
The cure shall be assessed in 3 follow up(0,7th,15th,30th)30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
13/11/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of study to find the effectiveness of Vasadi Kwath with Erand Tail in management of Vatarakta (Gout). The study will conducted in 33 patients showing sign and symptoms of Vatarakta. Serum Uric Acid levels will be done on the day of enrollment. Vasa, Aragvadha, Guduchi churna will be provided to the patient and will be asked to prepared kwath ( Decoction) and consumed 40ml of it. Medicine will be given for 30 days effect will be assessed in 3 follow up and result will be given on basis of proper statistical methods. |