| CTRI Number |
CTRI/2021/09/036926 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
23/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Anuvasan vasti ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the effect of medicated enema and giloya powder in the management of Gout. |
|
Scientific Title of Study
|
A Clinical Study on the effect of Basti Karma and Guduchi Churn in management of Vatarakta W.s.r to 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 Ragini kumari |
| Designation |
MD (Ay) scholar |
| Affiliation |
GACH PATNA |
| Address |
Dr Ragini kumari
MD(Ay) Scholar
Department of Kayachikitsa
Government Ayurvedic college patna
Dr Ragini kumari
MD (Ay) Scholar
Department of kayachikitsa
GACH Patna
Patna
BIHAR
800003
India |
| Phone |
7978937019 |
| Fax |
|
| Email |
raginirivansh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dineshwar prasad |
| Designation |
Professor Ex Principal GACH Patna |
| Affiliation |
ARYABHATT KNOWLEDGE UNIVERSITY |
| Address |
Flat No 205
Block A
Shantilok Apartment
Urmila Kunja
Sheikhpura Pillar No 75
patna
Mithapur
Patna
Patna
BIHAR
800014
India |
| Phone |
9470019814 |
| Fax |
|
| Email |
drdineshwarprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ragini kumari |
| Designation |
MD (Ay) scholar |
| Affiliation |
GACH PATNA |
| Address |
Dr Ragini kumari
MD(Ay) Scholar
Department of Kayachikitsa
Government Ayurvedic college patna
Dr Ragini kumari
MD (Ay) Scholar
Department of kayachikitsa
GACH Patna
Patna
BIHAR
800003
India |
| Phone |
7978937019 |
| Fax |
|
| Email |
raginirivansh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic college and hospital |
| Address |
Near Buddhmurti
Kadamkaun
Patna |
| 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 Ragini Kumari |
Government Ayurvedic college and hospital |
Room no 9
Pg department of kayachikitsa
Government Ayurvedic college and hospital
Near Buddhmurti
Kadamkaun
Patna
Patna
BIHAR |
7978937019
raginirivansh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchi Churn, Reference: Bhaishajya ratnawali 27/138-139, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -eranda taila), Additional Information: Annuvasan Basti with Guduchi taila |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having s.uric acid concentration more than 7 mg/dl in male and more than 6 mg/ dl in female.
Patients having sign & symptoms of vatarakta(Gout).
All three essential symptoms with or without non-essential symptoms like pain in affected joints,swelling in affected joints,loss of tactile sensation, redness,itching,burning sensation, discoloration of skin of affected joints.
|
|
| ExclusionCriteria |
| Details |
Patients having complications of Vatarakta (upadrava) like moorcha,hikka,etc.
Patients having secreting typhus.
Patients associated with HIV,Hepatitis and also pregnant woman. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in vatarakta |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in vatarakta |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
04/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Vatarakta is a metabolic disorder Which originates when we disturb our daily regime, dietary habits due to sedentary lifestyle. According to Acharya charaka vatarakta is vitiated vata having been obstructed in its passage by aggravated blood which effects the entire blood. Gout is marked by transient attacks of acute arthritis initiated by urine crystals deposited within and around joint. An attempt has been made on the management on vatarakta (gout) with Ayurvedic medicine in the form of BASTI KARMA (with guduchiTaila) & GUDUCHI CHURN with Eranda Taila as anupan,which is mentioned in ayurvedic texts. |