| CTRI Number |
CTRI/2024/09/074314 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Association of Vitamin D in Vatrakta (Gout) |
|
Scientific Title of Study
|
A case control study to assess the association of Serum Vitamin D in vatrakta (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 NEHA YADAV |
| Designation |
PG SCHOLAR ROGA NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt KHUSHILAL SHARMA GOVT (AUTO) AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8959168803 |
| Fax |
|
| Email |
yadavneha30648@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RITA SINGH |
| Designation |
READER OF ROG NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt KHUSHILAL SHARMA GOVT (AUTO) AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT KOLAR BYPASS NEHRU NAGAR BHOPAL MADHYA PRADESH 462003
SCIENCE HILLS BEHIND MANIT KOLAR BYPASS NEHRU NAGAR BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8435990799 |
| Fax |
|
| Email |
vd.ritu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NEHA YADAV |
| Designation |
PG SCHOLAR OF ROG NIDAN EVUM VIKRITI VIGYAN DEPARTMENT |
| Affiliation |
Pt KHUSHILAL SHARMA GOVT (AUTO) AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT KOLAR BYPASS ROAD NEHRU NAGAR BHOPAL MADHYA PRADESH 462003
SCIENCE HILLS BEHIND MANIT KOLAR BYPASS ROAD NEHRU NAGAR BHOPAL MADHYA PRADESH 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8959168803 |
| Fax |
|
| Email |
yadavneha30648@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
|
|
Primary Sponsor
|
| Name |
PT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
| Address |
SCIENCE HILLS BEHIND MANIT KOLAR NEHRU NAGAR BYPASS ROAD BHOPAL MADHYAPRADESH 462003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NEHA YADAV |
PT KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
DEPARTMENT OF ROG NIDAN EVUM VIKRITI VIGYAN ROOM NO 6 GROUND FLOOR SCIENCE HILLS BEHIND MANIT KOLAR BYPASS NEHRU NAGAR BHOPAL
Bhopal
MADHYA PRADESH |
8959168803
yadavneha30648@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE PT KLS AYURVEDA INSTITUTE BHOPAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E799||Disorder of purine and pyrimidinemetabolism, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with sign and symptoms of Vatarakta(Gout) as described in Ayurveda and Modern medical science between the age group of 21 to 60 years, either sex and irrespective of socioeconomic status.
2. Healthy individuals of age group of 21 to 60 years, either sex and irrespective of socioeconomic status.
3. Patients and healthy individuals willing to sign informed written consent for participation in the proposed research work. |
|
| ExclusionCriteria |
| Details |
1. Participants not fulfilling the inclusion criteria.
2. Patients and healthy individual not willing to sign the informed consent form for participating in research study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study we would be able to explain the role of Vitamin D in the cases of Vatarakta(Gout). |
At the end of the study we would be able to explain the role of Vitamin D in the cases of Vatarakta(Gout). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is further expected that this study will be helpful in clinical practice for the treatment and prevention of this disease. |
12 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2024 |
| 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="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
|
It is expected that at the end of the study we would be able to explain the role of Vitamin D in the cases of Vatarakta (Gout). It is further expected that this study will be helpful in clinical practice for the treatment and prevention of this disease. |