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 Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The primary outcome of the study is the change in body weight and BMI.
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age: Participants aged between 20 and 60 years.
- •Overweight Status: Individuals with a BMI (Body Mass Index) ranging from 25 to 30 kg/m², indicating overweight status.
- •Health Status: Participants without any significant medical conditions, such as cardiovascular diseases, diabetes, or metabolic disorders, that may interfere with the study outcomes.
- •Weight Stability: Individuals with stable body weight (±2 kg) for at least three months before the study initiation.
- •Willingness to Comply: Participants willing to adhere to the prescribed millet-based dietary intervention for the entire study duration.
- •Ability to Give Consent: Individuals capable of providing informed consent for participation in the study.
Exclusion Criteria
- •Age and Gender: Participants having age less than 20 years or more than 60 years are Excluded.
- •BMI Status: Individuals with a BMI below 25 kg/m² (not overweight) or above 30 kg/m² (obese).
- •Medical Conditions: Participants with a history of significant medical conditions, such as heart disease, diabetes, renal disorders, or thyroid dysfunction.
- •Allergies or Intolerances: Participants with known allergies or intolerances to millets or any components of the millet-based dietary intervention.
- •Pregnancy and Lactation: Pregnant or lactating individuals, as the dietary intervention may not be suitable during these periods.
- •Participation in Other Studies: Participants currently enrolled in other clinical studies or interventions related to weight management or nutrition.
- •Medication Use: Individuals taking medications or supplements known to affect weight or metabolic parameters.
- •Uncontrolled Hypertension: Participants with uncontrolled hypertension (systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg).
- •Mental Health Concerns: Individuals with significant mental health conditions or eating disorders that could affect dietary adherence.
Outcomes
Primary Outcomes
The primary outcome of the study is the change in body weight and BMI.
Time Frame: at baseline to 2 nd week of Intervention
after the millet-based dietary intervention. This outcome will assess the effectiveness of the millet
Time Frame: at baseline to 2 nd week of Intervention
diet in promoting weight reduction in participants with MedoVriddhi (overweight). Body weight
Time Frame: at baseline to 2 nd week of Intervention
will be measured at baseline (before the intervention) and at the end of the intervention period.
Time Frame: at baseline to 2 nd week of Intervention
Secondary Outcomes
- 1. Body Composition(2. Metabolic Parameters)
Investigators
viramgama jinal khodidasbhai
National institute of Ayurveda deemed to be university ,jaipur