| CTRI Number |
CTRI/2020/10/028225 [Registered on: 05/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Gout by Ayurvedic Drug |
|
Scientific Title of Study
|
An Etiopathological Study of Vatarakta wsr to Gout and therapeutic effect(Upshayatmak Parikshan) of Anshumati Kwath |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJAY KUMAR |
| Designation |
MD Scholar |
| Affiliation |
Government PG Ayurveda College and Hospital |
| Address |
room no 19 Department of Roga Nidan Academic Block
Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9369650255 |
| Fax |
|
| Email |
ajay4you3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avadhesh Kumar |
| Designation |
Reader and HOD |
| Affiliation |
Government PG Ayurveda College and Hosptal |
| Address |
room no 19 Department of Roga Nidan Academic Block
Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9455262663 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avadhesh Kumar |
| Designation |
Reader and HOD |
| Affiliation |
Government PG Ayurveda College and Hosptal |
| Address |
room no 19 Department of Roga Nidan Academic Block
Government PG Ayurveda College and Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9455262663 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government PG Ayurveda College and Hospital Varanasi UP 221001 |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and Hospital |
| Address |
Government PG Ayurveda College and Hospital Chaukaghat Varanasi |
| Type of Sponsor |
Government medical college |
|
|
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 Avadhesh Kumar |
Government PG Ayurveda College and Hospital |
room no 19 Department of Roga Nidan Academic block Government PG Ayurveda College and Hospital
Varanasi
UTTAR PRADESH |
9455262663
dravadheshsaroj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government PG Ayurveda college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anshumati Kwatha |
minimum 40 patients with Sign and Symptoms of Vatarakta will be given 20ml of Anshumati Kwatha twice daily for 30 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting with classical sign and symptoms of Vatarakta
patients of Hyperuricemia with Gouty arthritis |
|
| ExclusionCriteria |
| Details |
patients associated with metabolic disorder and systemic disease
patients of autoimmune joint disorder except RA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in sign and symptoms of vatarakta |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve quality of life of patients suffering from vatarakta |
45 days |
|
|
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 |
|
Date of First Enrollment (India)
|
06/10/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Under this clinical study minimum 40 patients of vatarakta will be treated with Anshumati Kwatha . the constituents of this drugs are Shunthi, Pippali, Shalparni which have the properties of Deepan, Shoolaprashaman, Angamarda prashaman, Shothahar, Balya, Snehopag activities according to ayurvedic view. on the other hand that ingredients show Anti-inflammatory, Analgesic, Lubericating activity according to modern view. Due to their above Properties this drug acts on remission of sign and symptoms of vatarakta. Period of trial will be of one month with seven days follow-up. patients will be selected from OPD and IPD and will be diagnosed on the basis of the sign and symptom along with laboratory investigation and radiological investigations., then assessment will be done and conclusion will be drawn after completion of study. |