| CTRI Number |
CTRI/2023/05/052927 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
18/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Open Label |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the occurrence of Gout based on Causative Factors, Blood Group and Body Constitution. |
|
Scientific Title of Study
|
An observational study to evaluate the prevalence of Hyperuricemia w.s.r. to Vatarakta on the basis of Etiological Factors, Blood Group and Prakriti of patient |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti |
| Designation |
Pg Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Room No. 98, PG Department of Rog Nidan Evum Vikriti Vigyan, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector- 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9817368654 |
| Fax |
|
| Email |
jtsharma1407@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti |
| Designation |
Pg Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Room No. 98, PG Department of Rog Nidan Evum Vikriti Vigyan, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector- 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9817368654 |
| Fax |
|
| Email |
jtsharma1407@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti |
| Designation |
Pg Scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Room No. 98, PG Department of Rog Nidan Evum Vikriti Vigyan, Shri Krishna Govt. Ayurvedic College and Hospital, Umri Road, Sector- 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9817368654 |
| Fax |
|
| Email |
jtsharma1407@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College and Hospital, Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt. Ayurvedic College and Hospital |
| Address |
Umri Road, Sector- 8, Kurukshetra |
| 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 Deepti Parashar |
Shri Krishna Govt. Ayurvedic College and Hospital |
Room No. 71 D, Department of Rog Nidan evum Vikriti Vigyan
Kurukshetra
HARYANA |
9468319931
drdeeptiamehta@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 |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Vatarakta (Hyperuricemia-Gout)
2. Patients willing to give written consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients except age group of 30 -60 years.
2. Patients not willing for consent.
3. Patients with communicable diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand the occurance rate of Vatarakta on the basis of etiological factors.
• To understand the occurance rate of Vatarakta on the basis of Blood Group.
• To understand the occurance rate of Vatarakta on the basis of Prakriti. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the occurance rate of Vatarakta on the basis of Prakriti. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
14/06/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
current scenario of lifestyle affects normal health status and cause the
innumerable pathology and Vata Rakta is one of among them. The patient of
Hyperuricemia is increasing day by day and is one of the highest prevalent
metabolic diseases. Therefore, to study Hyperuricemia on the basis of etiological
factor is taken into consideration and also to study the relation between Blood
Group and Prakriti of patient with Hyperuricemia. |