| CTRI Number |
CTRI/2025/02/081043 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the effectiveness of Erand Taila and Triphala Kwath in the treatment of Gout. |
|
Scientific Title of Study
|
APPLIED STUDY TO EVALUATE THE EFFICACY OF ERAND TAILA
& TRIPHALA KWATH IN VATARAKTA W.S.R. TO Virechasthapan Snehapanair Gambhiram Acharet |
| Trial Acronym |
ETTKV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lipsa Acharya |
| Designation |
PG scholar |
| Affiliation |
Govt Ayurvedic college and Hospital Kadamkuan Patna Bihar |
| Address |
Dept of Samhita Evum Siddhant
Govt Ayurvedic College and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
7788046784 |
| Fax |
|
| Email |
lipsa.acharya72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Vijay Shankar Pandey |
| Designation |
H.O.D |
| Affiliation |
Govt Ayurvedic college and Hospital Kadamkuan Patna Bihar |
| Address |
Dept of Samhita Evum Siddhant
Govt Ayurvedic College and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9334124587 |
| Fax |
|
| Email |
Vijmrs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Vijay Shankar Pandey |
| Designation |
H.O.D |
| Affiliation |
Govt Ayurvedic college and Hospital Kadamkuan Patna Bihar |
| Address |
Dept of Samhita Evum Siddhant
Govt Ayurvedic College and Hospital Kadamkuan Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9334124587 |
| Fax |
|
| Email |
Vijmrs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurvedic College and Hospital Kadamkuan Patna Bihar
pin 800003 India |
|
|
Primary Sponsor
|
| Name |
Govt Ayurvedic College and Hospital Kadamkuan Patna India |
| Address |
Dept of Samhita Evum Siddhant
Govt Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003 India |
| 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 Lipsa Acharya |
Govt Ayurvedic college and Hospital Kadam kuan Patna Bihar |
Dept. of Kaya Chikitsa, Anusandhana and Pancha Karma OPD No 9, 10, 11 respectively
Patna
BIHAR |
7788046784
lipsa.acharya72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: Erand taila and Triphala kwath, Reference: Ch. Chi 26/29, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Triphala Kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 30 yrs and less than 65 yrs. Patients uric acid conc. more than 7.0 mg/dl and more than 6.0 mg/dl in female. |
|
| ExclusionCriteria |
| Details |
Age more than 65 yrs. Patient having more than 50% joints involvement, having secreting tophus, with pregnancy , cancer and other life threatening diseases. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Erand taila and Triphala kwath in Vatarakta |
Baseline 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction of Inflammation,
pain, redness and swelling
2. Healthy movements of joints
3. No difficulty in walking or
doing work |
Baseline 30 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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 Yet Recruiting |
| 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
|
Gout is an inflammatory disease caused by the deposition of needle-like crystals of uric acid known as monosodium urate crystals in and around the synovial joints. It is an inborn error of purine metabolism characterized by pain and swelling of the first meta tarso phallangeal joint initialy followed by other joints. In Ayurveda gout is correlated with Vatarakta. In this disease Vata dosha and Rakta dhatu get vitiated simultaneously, having signs and symptoms resembling that of Gout. The drug used in this trial is Erand taila and Triphala kwath mentioned in the Ayurvedic text with the hope that it will prove efficient and less toxic and easily available. The duration of treatment is 30 days. Patients will be taken from OPD and IPD of Govt. Ayurvedic college and hospital Patna. |