| CTRI Number |
CTRI/2023/03/050484 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Talmakhana Amrita kwath in Vatarakta WSR to Gouty Arthritis |
|
Scientific Title of Study
|
A Clinical study on the efficacy of Talmakhana Amrita kwath in Vatarakta W.S.R to Gouty Arthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushil Kumar Jha |
| Designation |
MD(Ay) Scholar |
| Affiliation |
Government Ayurvedic College,Patna |
| Address |
Department of Kayachikitsa
Government Ayurvedic college
Kadam Kuan,Patna.
Bihar
PIN-800003
Patna
BIHAR
800003
India |
| Phone |
8969844669 |
| Fax |
|
| Email |
drsushil8969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Kayachikitsa
Government Ayurvedic College
Kadam Kuan
Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College Patna |
| Address |
Department of Kayachikitsa
Government Ayurvedic College
Kadam Kuan
Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
vijay.md09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College,Patna. |
|
|
Primary Sponsor
|
| Name |
DrSushil Kumar Jha |
| Address |
Department of kayachikitsa
Government Ayurvedic College
Kadam Kuan,Patna
PIN 800003 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government Ayurvedic CollegePatna |
kadam kuan
Patna
PIN 800003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr vijay Bahadur Singh |
Government Ayurvedic college ,Patna |
Room no 9
Department of kayachikitsa
Government Ayurvedic college & hospital
kadamkuan Patna,Bihar
PIN-800003
Patna
BIHAR |
7004642738
vijay.md09@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:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: disease of musculoskeletal system, (3) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, (4) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, (5) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, (6) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, (7) ICD-10 Condition:M048||Other autoinflammatory syndromes. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Talmakhana Amrita kwath, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having the clinical feature of vatarakta.
2.Patient having chronicity of vatarakta less than one year.
3.Patient willing to give consent for trial with firm residential address andf contact. |
|
| ExclusionCriteria |
| Details |
1.Age below 20 and above 60
2.Patient suffering from uncontrolled Diabetes,Hypertension,TB,AIDS. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
releif in
(1)joint pain
(2) inflammation
(3) tenderness
(4) redness |
14th,21th,35th and 42nd days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
releif in
(1)burning sensation
(2)Tophi
(3)numbness
(4)itching |
14th,21th,35th and 42nd days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2023 |
| Date of Study Completion (India) |
28/08/2023 |
| 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
|
Gout is an inflammatory crystalline arthritis characterised by red,hot,tender and swelling in joint with severe pain.In Ayurved Gout is found similar to vatrakta and Talmakhana Amrita kwath for its treatment.After considering these aspects present study has been designed to evaluate the efficacy of Talmakhana Amrita kwath in the management of vatrakta with special referenc to gouty arthritis. |