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CTRI Number  CTRI/2024/05/067304 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Use of Millets in management of obesity 
Scientific Title of Study   A Clinical Study of Millets [ Shyamaka (Echinochloa Frumentacea Linn.), Kodrava (Paspalum Scrobiculatum Linn) and Yavanala (Sorghum Vulgare Linn.)] in the Management Of Medovriddhi (Overweight)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  viramgama jinal khodidasbhai 
Designation  post-graduation scholar 
Affiliation  National institute of Ayurveda deemed to be university ,jaipur 
Address  Room no.137 department of Dravyaguna vigyana National institute of ayurvedic deemed to be university ,jaipur Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8200034452  
Fax    
Email  jinalviramgama88@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof A Rama Murthy  
Designation  M.D.Ph.D Professor 
Affiliation  National institute of Ayurveda deemed to be university ,jaipur 
Address  Room no.132 Department of Dravyaguana National institute of ayurvedic deemed to be university ,jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9314513659  
Fax    
Email  armurthy_2005@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr. viramgama jinal khodidasbhai 
Designation  post-graduation scholar 
Affiliation  National institute of Ayurveda deemed to be university ,jaipur 
Address  Room no.137 Department of Dravyaguna National institute of ayurvedic deemed to be university ,jaipur Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8200034452  
Fax    
Email  jinalviramgama88@gmail.com  
 
Source of Monetary or Material Support  
National institute of ayurvedic deemed to be university ,jaipur  
 
Primary Sponsor  
Name  National institute of Ayurveda Deemed to be university 
Address  JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
VIRAMGAMA JINAL KHODIDASBHAI  National institute of Ayurveda Deemed to be university  opd no.19, Department of dravyaguna,National institute of ayurveda ,jaipur
Jaipur
RAJASTHAN 		 8200034452

jinalviramgama88@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOJA-VRUDDHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: millets [shyamak ,kodrava and yavanal , Reference: charak samhita ,shusrut samhita and bhavprakash nighantu , Route: Oral, Dosage Form: Pramathya, Dose: 50(g), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: dosage form -it will be given as ahara dravya once in a a day at lunch time
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age: Participants aged between 20 and 60 years.
2. Overweight Status: Individuals with a BMI (Body Mass Index) ranging from 25 to 30 kg/m²,
indicating overweight status.
3. Health Status: Participants without any significant medical conditions, such as cardiovascular
diseases, diabetes, or metabolic disorders, that may interfere with the study outcomes.
4. Weight Stability: Individuals with stable body weight (±2 kg) for at least three months before
the study initiation.
5. Willingness to Comply: Participants willing to adhere to the prescribed millet-based dietary
intervention for the entire study duration.
6. Ability to Give Consent: Individuals capable of providing informed consent for participation
in the study.
 
 
ExclusionCriteria 
Details  1. Age and Gender: Participants having age less than 20 years or more than 60 years are Excluded.
2. BMI Status: Individuals with a BMI below 25 kg/m² (not overweight) or above 30 kg/m²
(obese).
3. Medical Conditions: Participants with a history of significant medical conditions, such as heart
disease, diabetes, renal disorders, or thyroid dysfunction.
4. Allergies or Intolerances: Participants with known allergies or intolerances to millets or any
components of the millet-based dietary intervention.
5. Pregnancy and Lactation: Pregnant or lactating individuals, as the dietary intervention may
not be suitable during these periods.
6. Participation in Other Studies: Participants currently enrolled in other clinical studies or
interventions related to weight management or nutrition.
7. Medication Use: Individuals taking medications or supplements known to affect weight or
metabolic parameters.
8. Uncontrolled Hypertension: Participants with uncontrolled hypertension (systolic blood
pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg).
9. Mental Health Concerns: Individuals with significant mental health conditions or eating
disorders that could affect dietary adherence.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is the change in body weight and BMI.
after the millet-based dietary intervention. This outcome will assess the effectiveness of the millet
diet in promoting weight reduction in participants with MedoVriddhi (overweight). Body weight
will be measured at baseline (before the intervention) and at the end of the intervention period.  		 at baseline to 2 nd week of Intervention  
 
Secondary Outcome  
Outcome  TimePoints 
1. Body Composition
2. Metabolic Parameters
3. Adherence to the Millet Diet
4. Safety & Adverse Events
5. Changes in Quality of Life: 		 at baseline to 4-6 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   01/06/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 MedoVriddhi is correlated with the overweight in the contemporary science. Obesity or overweight is a state of excess adipose tissue mass. An abnormal growth of adipose tissue due to an enlargement of fat cell size or an increase in fat cell number. The most widely used simple method for assessment of obesity or overweight is the body mass index (BMI), which is equal to weight/height (in kg/m2). According to WHO, A BMI between 25 and 29.9 is known as overweight. Obesity is defined as BMI greater than 30. The word “Millet” derived from the latin word “Milium” means small seed, Millets are a specific group of plant of Poaceae family containing smaller seed than major cereals. Millets have been used as food as well as therapeutic diet in Ayurveda since samhita kala. Government of India has taken a lead role and has launched widescale strategies to promote millets in order to make India a global hub for millets. In Ayurveda, Millets are mentioned under Kudhanya varga. In Sushruta Samhita specific kudhanya varga is described. Among them, Shyamak (Echinochioa frumentacea) Ushna, Kashay, Ruksha, Madhur rasa, Katu vipak, Kaphanasak. Kodrava (Paspulum scrobiculum)Ushna, Kashay, Ruksha, Madhur rasa, Katu vipak Kaphanasak In bhavprakash Nighantu, Yavanal is described in Trunadhanya or kudhanya. Yavanala (sorghum vulgare)Hima, Madhur, Kashay, Shleshampitajitam, Ruksha, Laghu Because millets have this kind of properties, we can use against the overweight.
 In this study total 30 patients will be managed by millets viz. shyamak ,kodrava and yavanala.this millets will be given as diet for once a day for 42 days .
The Ahara Dravya (dietary substance) administration in the study is planned to span a total duration of 6 weeks, divided into three distinct phases, each lasting for 2 weeks. During the initial 2 weeks of the study, participants will be required to incorporate one type of millet, chosen from a selection of three, into their lunchtime meal while adhering to their normal diet for dinner. Throughout the following 4 weeks, the study will continue with the same millet consumption pattern. One millet will be chosen for the once-daily lunch meal from the two remaining types of millets for two consecutive weeks at a time. This pattern will continue thoughout the study. Throughout the entire 6-week study period, participants will adhere to the prescribed millet consumption plan, allowing researchers to assess the effects of the millet-based dietary intervention on weight management and other relevant health parameters. This controlled dietary administration will enable a comprehensive evaluation of the potential benefits of millets in the management of MedoVriddhi (overweight).  
 
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