| CTRI Number |
CTRI/2024/07/070927 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between Serum Uric Acid and Urinary Uric Acid Levels in Vatarakta (Gout): Insights from Dhatwagni Siddhanta Perspective |
|
Scientific Title of Study
|
Assessment of Correlation of Serum Uric Acid and Urinary Uric Acid In Vatarakta Gout in the context of Dhatwagni Siddhant A Case Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIGVIJAY SINGH |
| Designation |
P.G SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital And Research Centre |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22, MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9897195260 |
| Fax |
|
| Email |
sdiggisingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Digvijay Singh |
| Designation |
PG Scholar |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22, MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA
Department of Samhita and Siddhant Division- 2 Room no- 22, MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9897195260 |
| Fax |
|
| Email |
sdiggisingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhushan Mhaiskar |
| Designation |
Associate Professor |
| Affiliation |
MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA |
| Address |
Department of Samhita and Siddhant Division- 2 Room no- 22, MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE SALOD (H) WARDHA MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
8983010655 |
| Fax |
|
| Email |
bhushan.mhaiskar@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital Sawangi (Meghe) Wardha Maharashtra 442004 Pin - 442001 INDIA |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha Maharashtra Pin - 442001 INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Digvijay Singh |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra Pin - 442001 INDIA |
| 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 Digvijay Singh |
Mahatma Gandhi Ayurved College ,Hospital and Research Centre Wardha (Hirapur) 442001 |
OPD and IPD Dept of Kayachikitsa MGACH&RC Salod (H) Wardha 442001
Wardha
MAHARASHTRA |
9897195260
sdiggisingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee Salod (H) ,Wardha-442004, Maharashtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M206||Acquired deformities of toe(s), unspecified. Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Patients of Age group 30-65 years irrespective of gender.
2. Provision of informed consent.
3. Confirmed diagnosis of Vatarakta (Gout) (for Group A).
|
|
| ExclusionCriteria |
| Details |
.patients of age under 30 years and above 65 years will be excluded from the study
. Individuals with known renal or hepatic diseases.
.Pregnant or lactating women.
. Individuals who were taking NSAIDs colchicine treatment Corticoids, Anticoagulants .Diabetic Patients, Diuretics or other drugs that alter uric acid Excretion .
. Patient with hepatic insufficiency (ALT or AST above 1.5 times the upper limit of normal And serum total bilirubin more than 2 times the upper limit of normal .
. Renal insufficiency ,active peptic ulcer combined with heart disease ,Malignant tumors ,active Tuberculosis or blood disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Generation of Empirical Data in favor of Dhatwagni Siddhant by Assessing correlation of Serum uric acid and Urinary uric acid in Vatarakta (Gout) |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identifying the most critical parameters by analyzing serum uric acid & urinary uric acid in the context of Dhatwagni Siddhant in Vatarakta (Gout) |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/08/2024 |
| 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="2"
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
|
The volunteers will be informed about the study protocol .Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and Validated prior to the study approval will be taken from IEC, MGACHRC, SALOD (H) Wardha and CTRI RAGISTRATION will be done . after selection each participant will be tested individually and selected according to selection criteria . They will be divided into two groups as the case group and control group . it will include 30 patient in each group . |