| CTRI Number |
CTRI/2024/05/067375 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of virechana Karma With trivrit Churna in Vatarakta w.s.r to Gout. |
|
Scientific Title of Study
|
A clinical study on the effect of Virechan karma with Trivrit churn in the management of Vatrakta w.s.r to 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.Aditya Prasad Satapathy |
| Designation |
MD( Ay.) Scholar(Panchakarma) |
| Affiliation |
Government Ayurvedic college & Hospital,near budhmurti,Kadamkuan,patna. |
| Address |
Department of Panchakarma
Government Ayurvedic college & Hospital,
near budhmurti,Kadamkuan,patna.
Patna
BIHAR
800003
India |
| Phone |
7008146525 |
| Fax |
- |
| Email |
adityasatapathy10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilesh Prasad Singh |
| Designation |
H.O.D, Associate Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic college & Hospital,near budhmurti,Kadamkuan,patna. |
| Address |
Department of Panchakarma
Government Ayurvedic college & Hospital,near Budhmurti,Kadamkuan,patna.
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
- |
| Email |
drapsinghpatna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilesh Prasad Singh |
| Designation |
H.O.D, Associate Professor Department of Panchakarma |
| Affiliation |
Government Ayurvedic college & Hospital,near budhmurti,Kadamkuan,patna. |
| Address |
Department of Panchakarma
Government Ayurvedic college & Hospital,near budhmurti,Kadamkuan,patna.
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
- |
| Email |
drapsinghpatna@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college & Hospital,near budhmurti,Kadamkuan,patna,Bihar. |
|
|
Primary Sponsor
|
| Name |
DrAditya Prasad Satapathy |
| Address |
Department of Panchakarma
Government Ayurvedic college & Hospital,near Budhmurti,Kadamkuan,patna. |
| 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 |
| Dr Aditya Prasad Satapathy |
Government Ayurvedic College and Hospital. |
OPD no -11,
Department of Panchakarma,
Kadamkuan,near budhmurti,Patna,800003
Patna
BIHAR |
7008146525
-
adityasatapathy10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) |
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 | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: charak samhita chikitsa sthan 29/41, Procedure details: As pre operative procedure post deepan and pachana, shodhan snehpana will be done for 5 days followed by 3 days of rest along with bahya snehan and swedana and finally virechana karma on the 4th day.)
(1) Medicine Name: Trivrit churna, Reference: charak samhita chikitsa sthan 29/84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Serum uric acid conc. more than 7.0mg/dl in male and more than 6.0 mg/dl in female. Patients having their age more than 18 years and below 70 years.
Patients having sign & symptoms of vatarakta (Gout).
All three essential symptoms with or without non-essential symptoms. Essential criteria:-
1. pain in affected joint.
2.swelling in the affected joint.
3.loss of tactile sensation. Non-essential criteria:-
1.redness in affected joint.
2.itching in affected joint.
3.burning sensation over joint.
4.discoloration of skin of affected joint. |
|
| ExclusionCriteria |
| Details |
Patients of age below 18 and above 70 years.
Patients having complications of vatarakta (upadrava) like, moorcha, hikka etc.
Patients having secreting tophus.
Patients associated with HIV, Hepatitis and also pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The improvement in the patients will be assessed mainly on the basis of relief in the cardinal symptoms of disease. To access the effect of therapy subjectively, all the sign & symptoms will be relief in
1.pain in affected joint.
2.swelling in the affected joint.
3.laws of tactile sensation. upon their severity. |
55days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The analysis of the values of the serum uric acid will be done before & after the treatment and during the follow up to compare the condition of affected joints. |
55days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/05/2024 |
| 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="0"
Months="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [adityasatapathy10@gmail.com].
- For how long will this data be available start date provided 25-04-2025 and end date provided 02-02-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is randomised open interventional prospective trail to study the effect of virechana karma by trivrit churna in the management of vatarakta with special reference to gout in a group of 30 patients. This study will be conducted in Government Ayurvedic College and Hospital,patna,Bihar in the department of Panchakarma. After 25 days of intervention two follow up will be done every 15 days for total duration of study i.e of 55 days |