| CTRI Number |
CTRI/2025/08/092985 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find the Association between the consumption of incompatible foods and the diagnosed Amavata Patients. |
|
Scientific Title of Study
|
A Case Control study to find the Association of Samyog Viruddha Kshirjanya Aahar Consumption in diagnosed Amavata patients. |
| 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 Snehal Vishwas Shinde |
| Designation |
B.A.M.S. PG SCHOLAR |
| Affiliation |
PDEAs College of Ayurved And Research Centre Nigdi Pune. |
| Address |
PDEAs College of Ayurved And Research Centre Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology lab room no. 115 sector no. 27 Pradhikaran Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9822673141 |
| Fax |
|
| Email |
snehalshinde250@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved And Research Centre Nigdi Pune. |
| Address |
PDEAs College of Ayurved And Research Centre Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology lab room no. 115 sector no. 27 Pradhikaran Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved And Research Centre Nigdi Pune. |
| Address |
PDEAs College of Ayurved And Research Centre Ayurved Rugnalay and Sterling Multispeciality Hospital Pathology lab room no. 115 sector no. 27 Pradhikaran Nigdi, Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Snehal Vishwas Shinde |
PDEAs Ayurved Rugnalay and Multispeciality Hospital. |
Pathology Lab, Room No.115, Sector 27, Pradhikaran, Nigdi, Pune
Pune
MAHARASHTRA |
9822673141
snehalshinde250@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, PDEAs College of Ayurved and Research Centre, Sector No. 25, Pradhikaran, Nigdi, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M048||Other autoinflammatory syndromes. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Case Group:
1. Diagnosed Amavata patients.
2. Gender-Both Male and Female
3. Patients between age-20-50 years will be selected.
Control Group:
1. Healthy individual.
2. Gender-Both Male and Female
3. Patients between age-20-50 years will be selected. |
|
| ExclusionCriteria |
| Details |
Case Group:
1. Patients suffering from any systemic disorder like uncontrolled Diabetes Mellitus, uncontrolled Hypertension, Thyroid diseases.
2. Known case of Rheumatic fever, Rheumatic heart diseases, Juvenile Rheumatic arthritis, Pregnancy.
3. Malignancy – Systemic lupus erythematosus, Disseminated intravascular coagulation.
Control Group:
1. Healthy individual with other systemic disorder like uncontrolled Diabetes Mellitus, uncontrolled Hypertension, Thyroid diseases.
2.Malignancy –Systemic lupus erythematosus, Disseminated intravascular coagulation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the Association of Samyog Viruddha Kshirjanya Aahar Consumption in diagnosed Amavata patients. |
1 time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable. |
Not applicable. |
|
|
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)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="5" |
|
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
|
1. Title A Case Control study to find the Association of Samyog Viruddha Kshirjanya Aahar Consumption in diagnosed Amavata patients. 2. Objective Primary Objectives:
To find the Association of Samyog Viruddha Kshirjanya Aahar Consumption in diagnosed Amavata patients. 3. Methodology: 1) Study Design: Case Control Study.
2) Study Setting: - Study Duration: 18 months. - Study Place: OPD and IPD attached to Institutional hospital.
The proposed study :
Level 1 (Conceptual) Ayurvedic literature regarding Amavata and Samyog Viruddha Kshirjanya Aahar will be studied from Samhitas and also from internet articles and research paper. Level 2 (Observational) Observation about the consumption of Samyog Viruddha Kshirjanya Aahar in both Case and Control group. Level 3 (Analytical) Analysis of generated data will be performed for results in percentage form. 4. Study Population: 1) Case group:- Diagnosed Amavata patients between the age group of 20 to 50 of either sex will be selected. 2) Control Group:- Healthy individual between the age group of 20 to 50 of either sex will be selected.
5. Sample Size: 30 patients from both case and control group will be taken. total 60 patients will be taken.
6. Appropriate Sampling Technique: Case Group : Purposive Sampling technique will be taken. Control Group: Purposive Sampling technique will be taken.
7. Method of selection of study subject: 1) Case Group:
- Inclusion Criteria:
1. Diagnosed Amavata patients. 2. Gender-Both Male and Female. 3. Patients between age 20-50 years will be selected. - Exclusion Criteria: 1. Patients suffering from any systemic disorder like uncontrolled Diabetes Mellitus, uncontrolled Hypertension, Thyroid diseases. 2. Known case of Rheumatic fever, Rheumatic heart diseases, Juvenile Rheumatic arthritis, Pregnancy. 3. Malignancy - Systemic lupus erythematosus, Disseminated intravascular coagulation. 2) Control Group: - Inclusion Criteria: 1. Healthy individual. 2. Gender-Both Male and Female 3. Patients between age 20-50 years will be selected. - Exclusion Criteria: 1. Healthy individual with other systemic disorder like uncontrolled diabetes Mellitus, uncontrolled Hypertension, Thyroid diseases. 2. Malignancy -Systemic lupus erythematosus, Disseminated intravascular coagulation.
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