| CTRI Number |
CTRI/2023/05/053054 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
20/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the proneness & severity of vatarakta in specific Prakriti individuals |
|
Scientific Title of Study
|
Assessment of Association between Prakriti and Vatarakta- A Cross-Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanju Kumari |
| Designation |
PG Scholar, Department of KriyaSharir |
| Affiliation |
CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
Ch. Brahm Prakash Ayurved Charak Sansthan, Institutional block, 3rd floor, Khera Dabar, Najafgarh-110073
Khera Dabar,Najafgarh, New Delhi-73
South West
DELHI
110073
India |
| Phone |
7838114389 |
| Fax |
- |
| Email |
kashyapsanju960@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alok Kumar Asthana |
| Designation |
Associate professor, dept. of Kriyasharir |
| Affiliation |
CBPACS |
| Address |
CBPACS,Institutional block, Khera Dabar, Najafgarh, New Delhi-73
South West
DELHI
110073
India |
| Phone |
8295438040 |
| Fax |
|
| Email |
Alokayurlife@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanju kumari |
| Designation |
PG Scholar, PG dept of Kriyasharir |
| Affiliation |
CBPACS |
| Address |
CBPACS, Khera Dabar, Najafgarh, New Delhi-73
South West
DELHI
110073
India |
| Phone |
7838114389 |
| Fax |
|
| Email |
kashyapsanju960@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Village Khera Dabar, Najafgarh, New Delhi-73 |
| 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 Sanju Kumari |
Ch Brahm Prakash Ayurved Charak Sansthan |
Institutional Block, 3rd floor, Kriyasharir Department,Khera Dabar ,Najafgarh, New Delhi-73
South West
DELHI |
7838114389
0
Kashyapsanju960@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged 20 - 50 years of either gender
2. Individuals who consent in writing to participate in the study
3. Individuals presenting with clinical features of vatarakta, irrespective of gender and socio-economic status
4. Individuals presenting clinical features of gouty arthritis with hyperuricemia. |
|
| ExclusionCriteria |
| Details |
1. Mentally unstable individuals
2. Individuals who have or have had a past history of a malignant tumor
3. Pregnant and lactating women
4. Individuals with autoimmune disorders of joints, infective and reactive arthritis
5. Individuals with severe toxicity, ulceration, progressive gangrenous changes.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing vatarakta & its severity in specific Prakriti using sign & symptoms mentioned in classical text & using ACR/EULAR criteria then assessing Prakriti by using validated prakriti proforma. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the role of diet & lifestyle in prevention of vatarakta in various prakriti & designing treatment protocols. |
15-365 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/05/2023 |
| 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="0"
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
|
This is an observational type of study assessing the association between types of Prakriti & vatarakta w.s.r to severity of vatarakta in specific Prakriti. This study will be conducted for a time period of one year in CBPACS with outcome of specifically designed diet & lifestyle, treatment protocols, and with the prevalence of vatarakta being studied in different Prakriti subjects preventive measures could also be taken. |