| CTRI Number |
CTRI/2024/06/068246 [Registered on: 03/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the management of ashwatha ghanavati in vatarakta (gout) |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF ASHWATHA GHANAVATI IN THE MANEGMENT OF VATARAKTA (GOUT) |
| 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 Komal Popat Sonawane |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil College Of Ayurveda And Research Center Pimpri Pune |
| Address |
Dr.D.Y.Patil College Of Ayurveda And Research Center Sant Tukaram Nagar ,pimpri ,pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8208190218 |
| Fax |
|
| Email |
sonawanekomal755@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digambar G Dipankar |
| Designation |
Professor (Kayachikitsa) |
| Affiliation |
Dr.D.Y.Patil College Of Ayurveda And Research Center Pimpri Pune |
| Address |
OPD No 5 and IPD of kayachikitsa department Dr.D.Y.Patil College Of Ayurveda And Research Center Sant Tukaram Nagar ,pimpri ,pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
digambar.dipankar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digambar G Dipankar |
| Designation |
Professor (Kayachikitsa) |
| Affiliation |
Dr.D.Y.Patil College Of Ayurveda And Research Center Pimpri Pune |
| Address |
OPD No 5 and IPD of kayachikitsa department Dr.D.Y.Patil College Of Ayurveda And Research Center Sant Tukaram Nagar ,pimpri ,pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
digambar.dipankar@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research Center Sant Tukaram nagar, pimpri ,pune |
|
|
Primary Sponsor
|
| Name |
Dr. Komal Popat Sonawane |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Center Sant Tukaram nagar, pimpri ,pune 411018 |
| 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 |
| DrKomal Sonawane |
Dr D Y Patil College of Ayurveda And Research Center Pimpri Pune |
OPD No 5 and IPD of Kayachikitisa Department Of Dr DY Patil College of Ayurveda And Research Center Pimpri Pune 422018
Pune
MAHARASHTRA |
8208190218
sonawanekomal755@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwatha Ghanavati, Reference: Charak Chikitsasthan and Bhavprakash Nighantu , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical symptoms of vatarakta like pain in joint,swelling,burning sensation,tenderness at joints , stiffness,local colour changes
Sr uric acid level 3-12mg/dl |
|
| ExclusionCriteria |
| Details |
Patients with severe form of other systemic disorder like cardiac disease ,renal failure ,CAV will be excluded.
Pregnant women and lactating mother
Injury requiring surgical interventions
Any condition interfering the course of treatment were excluded
Secondary hyperuricemia due to leukemia ,lypoma,polycythemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in symptoms: intense pain, swelling, stifness, and decrease in serum uric acid of pts. |
30 days study with follw up on 15th and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To obeserve any adverse effect if any |
30 days study follw uo on 15th, 30th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
23/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
TO STUDY THE EFFICACY OF ASHWATHA GHANAVATI IN THE MANEGMENT OF VATARAKTA (GOUT) . TOTAL 30 PATIENTS WILL BE ENROLLED HAVING SYMPTOMS OF VATARAKTA(GOUT) . 2 TABLETS OF 500MG WILL BE GIVEN ADMINISTRATED TWICE A DAY ALONG WITH LUKEWARM WATER FOR DURATION OF 30 DAYS AND FOLLOW UP WILL BE DONE ON 15TH AND 30TH DAY AND FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHOD. |