| CTRI Number |
CTRI/2023/08/056963 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of Dhatryadi kwath and Vasadi kwath in management of Vatarakta (Gout). |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare the efficacy of dhatryadi kwath and vasadi kwath in management of vatarakta. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Ravindra Namdev Sagbhor |
| Designation |
Lecturer |
| Affiliation |
Rashtriya Shikshan Mandal,Tilak Ayurved Mahavidyalaya,583/2,Rasta Peth,Pune. |
| Address |
Sangam Sevabhavi Trust Ayurved Mahavidyalaya, Staff quarter Kayachikita department, Room no.4, Gunjalwadi, Nashik-Pune Highway, Sangamner.
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9763444204 |
| Fax |
|
| Email |
dr.ravisagbhor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd.Sadanand Vitthal Deshpande |
| Designation |
Professor, HOD, Principal |
| Affiliation |
Rashtriya Shikshan Mandal,Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune. |
| Address |
Rashtriya Shikshan Mandal,Tilak Ayurved Mahavidyalaya,583/2,Rasta Peth,Pune.
Rashtriya Shikshan Mandal,Tilak Ayurved Mahavidyalaya,583/2,Rasta Peth,Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
09960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd.Ravindra Namdev Sagbhor |
| Designation |
Lecturer. |
| Affiliation |
Rashtriya Shikshan Mandal,Tilak Ayurved Mahavidyalaya,583/2,Rasta Peth,Pune. |
| Address |
Sangam Sevabhavi Trust Ayurved Mahavidyalaya,Staff quarter Kayachikita department,Room no.4,Gunjalwadi,Nashik-Pune Highway,Sangamner.
Ahmadnagar
MAHARASHTRA
422604
India |
| Phone |
9763444204 |
| Fax |
|
| Email |
dr.ravisagbhor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramanath dharmarth hospital rasta peth pune |
|
|
Primary Sponsor
|
| Name |
Vd Ravindra Namdev Sagbhor |
| Address |
Sangam Sevabhavi Trust Ayurved Mahavidyalaya,Gunjalwadi,Nashik-Pune Highway,Sangamner. Pin Code-422605 |
| 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 |
| Vd Ravindra Namdev Sagbhor |
Seth Tarachand Ramnath Dharmarth Ayurvedic Rugnalaya,Pune |
Kayachikita Department, OPD No.5,Rasta Peth,Pune
Pune
MAHARASHTRA |
9763444204
dr.ravisagbhor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Tilak Ayurved Mahavidyalaya,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M1A9||Chronic gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: vasadi kwath, Reference: yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: erandtail), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: dhatradi kwath, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having signs and symptoms of vatarakta like shotha,kathinya,vedanadhikya,daha,Tod,shyavata/tamrata,spuran.
Patient of any sex, religion and socio-economic status.
2.newly diagnosed patient.
3.Patient with serum uric acid >7mg/dl in male and 6mg/dl in female. |
|
| ExclusionCriteria |
| Details |
1.Pathophysiology or genetic syndrome associated with vatarakta.
2.patient in serious symptoms like paak,khanja,pangulya and sandhivakrata are excluded.
3 malignancy, poorly controlled DM,HTN.
4.symptomatic patient with clinical evidence of heart failure.
5.complicated patient having target organ damage.
6.alcoholic and drug abusers, pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the classical sign and symptoms of vatarakta. |
30th, 60th, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess efficacy of Dhatryadi kwath & Vasadi kwath in management of Vatarakta.
2.To assess any adverse effects of Dhatryadi kwath & Vasadi kwath in management of Vatarakta.
3.Decrease in serum uric acid level. |
30th, 60th,, 90th day |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 3 |
|
Date of First Enrollment (India)
|
04/09/2023 |
| 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="3"
Months="0"
Days="0" |
|
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
|
The aim of study is to compare clinically the efficacy of Dhatryadi kwath with madhu and Vasadi kwath with Erandtail in management of Vatarakta (gout). To study in detail about vatarakta according to ayurvedic classics and observe any adverse effects. The trial will be conducted on 150 patients showing sign and symptoms of vatarakta in 02 groups, also serum uric acid level will be checked on the day of patient enrollment. Medicine will be given for 90 days, at the interval of 30 days patients will be assess the effect of therapy on objective parameters as well as subjective parameters. after 90 days of trial collected data of subjective and objective parameters will be statistically assess and conclusion will be drawn. |