| CTRI Number |
CTRI/2026/01/100278 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the Association of Black Gram, Curd and Radish Consumption with High Uric Acid Levels in Adults with Gout |
|
Scientific Title of Study
|
Charakokta Aahariya Hetu Maash Dadhi and Mulak Sevan as a Causative Factor of Vatarakta with Special Reference to Uric Acid - An Observational 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 |
Dr Dipali Solanke |
| Designation |
PG Scholar |
| Affiliation |
D. M. M. Ayurved Mahavidyalaya, Yavatmal |
| Address |
Rognidan ane Vikruti Vigyan Department, D.M.M. Ayurved Mahavidyalaya, Yavatmal
Shivaji Nagar, Arni Road, Yavatmal
Yavatmal MAHARASHTRA 445002 India |
| Phone |
8380862535 |
| Fax |
|
| Email |
solankedipali83@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Umesh Patil |
| Designation |
Head of Department and Associate Professor |
| Affiliation |
D. M. M. Ayurved Mahavidyalaya, Yavatmal |
| Address |
D.M.M. Ayurved Mahavidyalaya, Yavatmal
Shivaji Nagar, Arni Road, Yavatmal
Yavatmal MAHARASHTRA 445002 India |
| Phone |
9421312194 |
| Fax |
|
| Email |
drumeshpatil111@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dipali Solanke |
| Designation |
PG Scholar |
| Affiliation |
D. M. M. Ayurved Mahavidyalaya, Yavatmal |
| Address |
Rognidan and Vikruti Vigyan Department, D.M.M. Ayurved Mahavidyalaya, Yavatmal
Shivaji Nagar, Arni Road, Yavatmal
Yavatmal MAHARASHTRA 445002 India |
| Phone |
8380862535 |
| Fax |
|
| Email |
solankedipali83@gmail.com |
|
|
Source of Monetary or Material Support
|
| L. K Ayurved Rugnalaya, Yavatmal
Shivaji Nagar, Arni Road, Yavatmal, Maharashtra, India - 445001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Dipali Solanke |
L. K. Ayurved Rugnalaya, Yavatmal |
OPD No. 10 - Kayachikitsa and 14 - Panchakarma, Under the Department of Rognidan and Vikruti Vigyan, Yavatmal Yavatmal MAHARASHTRA |
8380862535
solankedipali83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMM Ayurved Mahavidyalya, Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M10||Gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical symptoms of Vatarakta, such as:
Kandu (Itching)
Sandhi Daha (Burning sensation in joints)
Sandhi Ruja (Joint pain)
Sandhi Toda (Pricking pain in joints)
Sandhi Shyavata (Cyanosis or discoloration over joints)
Sandhi Shotha (Edema or swelling of joints)
Sandhi Kathinya (Stiffness of joints)
Sandhi Sphurana (Throbbing sensation in joints) |
|
| ExclusionCriteria |
| Details |
1. Subjects who are non-compliant with the study protocol.
2. Individuals below 30 years of age and above 60 years
3. Pregnant and lactating women.
4. Patients presenting with the following conditions will be excluded:
o AIDS
o Chronic or acute liver disorders
o Any systemic illness or metabolic disorder that may influence serum uric acid levels other than Vatarakta. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare serum uric acid levels in individuals with Vatarakta and age and sex matched controls and to evaluate their association with the dietary consumption of Maash Dadhi and Mulak. |
At baseline |
|
|
Secondary Outcome
|
|
|
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)
|
15/01/2026 |
| 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 Yet Recruiting |
| 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
|
This observational case control study is planned to evaluate the association between certain dietary factors described in Ayurveda and the occurrence of Vatarakta with special reference to serum uric acid levels. According to classical Ayurvedic texts Maash Dadhi and Mulak are mentioned as important dietary causative factors for Vatarakta. From a modern perspective Vatarakta is correlated with gout which is characterised by elevated serum uric acid levels.
The study will include individuals aged between thirty and sixty years and will be conducted by comparing patients diagnosed with Vatarakta with age and sex matched healthy controls. Dietary intake of Maash Dadhi and Mulak will be assessed using a structured questionnaire and serum uric acid levels will be measured using standard biochemical methods.
The primary purpose of the study is to assess whether regular consumption of Maash Dadhi and Mulak is associated with higher serum uric acid levels and increased occurrence of Vatarakta. The hypothesis of the study is that intake of these Charakokta dietary factors is associated with elevated serum uric acid levels and the manifestation of Vatarakta. |