| CTRI Number |
CTRI/2024/04/065951 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Diet module] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Millet Diet in Dyslipidemia |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the effect of Millet based diet module in MEDOJA VIKARA W.S.R. to Dyslipidemia |
| 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 Kashinath Samagandi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Room no 204 PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashinath Samagandi |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Room no 204 PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Saini |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Room no 201 PG Department of Swasthavritta and Yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
DEEPAK SAINI
India |
| Phone |
9461046231 |
| Fax |
|
| Email |
95deepaksaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
| 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 Deepak Saini |
National Institute of Ayurveda |
OPD no 21 Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN |
09461046231
95deepaksaini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E756||Lipid storage disorder, unspecified. Ayurveda Condition: MEDOROGAH, (2) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Diet Module, Ritucarya: Diet Module, Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Vajranna Nirmita Kritanna
Shyamaka Nirmita Kritanna, Apathya:As per the condition | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna Tvak Churna, Reference: Bhaishjya Ratnavali chapter no 33 shlok 11, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 65 years irrespective of gender cast and religion
Patients of Dyslipidaemia having serum LDL cholesterol levels more then 100 mg/dL with or without Total cholesterol levels more then 200 mg/dL HDL Cholesterol levels less then 40 mg/dL Triglycerides levels more then 150 mg/dL
No acute or chronic pathology
Patients who will give consent
|
|
| ExclusionCriteria |
| Details |
Any renal or hepatic disease or a heart condition
Uncontrolled endocrine disease diabetes mellitus or gastrointestinal disease interfering with drug absorption
Undergoing other therapies for high cholesterol or anticoagulant therapy
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum levels of LDL |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum levels of Total Cholesterol, HDL, VLDL, Triglycerides |
12 weeks |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="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
|
| Need of study: Allopathic hypolipidaemic drugs being used today have more adverse effects. Taking Ayurvedic Prescriptions for Dyslipidaemia for a long duration also becomes difficult in feasibility and economical aspects. Therefore, use of a dietary module which has slight side effects or is free from side effects is a need and necessity in the management of Dyslipidaemia. Millets have been gaining popularity in the present contexts as superfoods. They have been praised for their high nutritional values which has led to the celebration of the year 2023 as the ‘International Year of Millets 2023’. Epidemiological studies predict that for each 1% reduction in lipid level, the risk of Heart diseases reduces by 2.5%.[9] Keeping this fact in mind, this work is being done to evaluate the efficacy of Pearl Millet and Barnyard Millet, two important millets in Dyslipidaemia, a well-recognized risk factor for the increasing incidence of Cardiovascular diseases. Aim and Objectives: Aim: To study and evaluate the effect of Millet-based diet module in Medoja Vikara wsr to Dyslipidaemia. Primary Objective: Evaluate the effect of Millet-based diet module in Medoja Vikara/Lipid Profile. Secondary Objective: To compare the Millet-based diet module with the standard control group in lipid profile, BMI, skin fold thickness and Waist-hip ratio of patients with Dyslipidaemia. Research Questions: Does millet-based diet module have effect in Changing the lipid profile of patients presenting with dyslipidaemia? Null Hypothesis: Millet based diet module does not have any effect in changing lipid profile of patients of Dyslipidaemia. | |