| CTRI Number |
CTRI/2025/03/082774 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study Vatarakta with Special Reference to Gout And effect of Peepal Twak Kwath in it. |
|
Scientific Title of Study
|
An Aetiopathological Study of Vatarakta with Special Reference to Gout and its Upashayatmaka Study of Peepal Twak Kwath. |
| 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 Akanksha Joshi |
| Designation |
MD Scholar Rog Nidan |
| Affiliation |
Government Ayurvedic College and Hospital,Kadamkuan, Patna |
| Address |
Government Ayurvedic College and Hospital Patna
Aryabhatta Knowledge University Patna
Patna
BIHAR
800003
India |
| Phone |
7088322972 |
| Fax |
|
| Email |
Akanksha20dec@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor (Head of Department) |
| Affiliation |
Government Ayurvedic College and Hospital,Kadamkuan, Patna |
| Address |
Department of Rog Nidan Evam Vikriti Vigyan
Government Ayurvedic College and Hospital Patna
Aryabhatta Knowledge University Patna
Patna
BIHAR
800003
India |
| Phone |
7004568326 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basant Kumar Thakur |
| Designation |
Professor (Head of Department) |
| Affiliation |
Government Ayurvedic College and Hospital,Kadamkuan, Patna |
| Address |
Department of Rog Nidan Evam Vikriti Vigyan
Government Ayurvedic College and Hospital Patna
Aryabhatta Knowledge University Patna
Patna
BIHAR
800003
India |
| Phone |
7004568326 |
| Fax |
|
| Email |
drbkthakur@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital,Kadamkuan, Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital,Kadamkuan, Patna |
| Address |
Department of Rog Nidan Evam Vikriti Vigyan
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar 800003 |
| 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 |
| DrAkanksha Joshi |
Government Ayurvedic College And Hospital |
Department Of Rog Nidan Evam Vikriti Vigyan Government Ayurvedic College And Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR |
7088322972
akanksha20dec@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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: peepal twak kwath, Reference: Charak Chikitsa chapter 29/158, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.The patient having age between 20 to 60 years
2.The patient’s sign and symptoms should be based on both ayurvedic as well as modern view. |
|
| ExclusionCriteria |
| Details |
1.Age above 60 and less than 20 years.
2.Immunocompromised patients e.g. HIV etc.
3.Severe deformities.
4.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sparshaagatwam (Loss of tactile sensation)
2.Kshate Atiruk (Severe pain on slight injury or tenderness)
3.Sandhi Shool (Severe pain in affected joint)
4.Vaivarnya (Discoloration)
5.Sandhi Shotha (Swelling)
6.Kandu (Itching)
7.Daha (Burning senation over joint) |
The assessment of patient will be done at interval of 15 days during the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sr. Uric Acid |
The assessment of patient will be done at interval of 15 days during the treatment |
|
|
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)
|
01/05/2025 |
| 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 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
|
This study is open label single arm clinical trial to determine the efficacy of Peepal Twak Kwath in Vatarakta for the age group of 20 to 60 years for 60 days . Study will be conducted at Government Ayurvedic College and Hospital, Patna, Bihar on 30 patients.Assessment will be done on the basis of subjective and objective parameters. Study will be conducted as OPD/IPD level of PG Department of Rog Nidan.The Assessment will be done at interval of 15 days of clinical trial and result obtained will be tabulated and statistically analyzed using appropriate test. |