Comparative Effects of Using Black Seed and Cumin Seed on BCP of Obese Grade I

Study Overview
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Brief Summary
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The goal of this Randomized clinical trial is to compare effectiveness of of using black seed (Nigella sativa) and cumin seed (Cuminum cyminum) on Body composition profile of obese grade 1. The primary objective of this study is To compare effectiveness of of using black seed (Nigella sativa) and cumin seed (Cuminum cyminum) on Body composition profile of obese grade 1. Subjects will be given a consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria.

Detailed Description
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Obesity is a global pandemic that is associated with high morbidity and mortality. Natural herbs are commonly used for weight reduction and appetite suppression. Worldwide data based on 1698 studies has shown that the global prevalence of obesity has increased from 3.2 to 10.8% in men and from 6.4 to 14.9% in women. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigella sativa which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of N. sativa have also been indicated. The antihyperglycemic activity, inhibition of free radical formation, anti-obesity and anti-inflammatory activity of cumin seed extract have also been reported previously.

Official Title
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Comparative Effects of Using Black Seed (Nigella Sativa) and Cumin Seed ( Cuminum Cyminum) on Body Composition Profile of Obese Grade I

Conditions
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Obese

Intervention / Treatment
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* Dietary Supplement: Black Seed ( Nigella Sativa)
* Dietary Supplement: Cumin Seed (Cuminum Cyminum)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject having BMI between 30 kg/m2 - 34.5 kg/m2 Exclusion Criteria: Subjects having kidney or liver problems Having ulcers in GIT Subjects having hypertension, thyroid, diabetes or cardiovascular disorders Pregnant and lactating mothers Subjects who are using hormonal or anti-obesity medications

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A Obese Grade I | Dietary Supplement: Black Seed ( Nigella Sativa)<br>* Intervention will be given once a day for 1 month, total 30 days Data will be collected at baseline and at the end of the intervention at 30th day<br>|
| Active Comparator: Group B<br>Group B Obese Grade I | Dietary Supplement: Cumin Seed (Cuminum Cyminum)<br>* Intervention will be given once a day for 1 month, total 30 days Data will be collected at baseline and at the end of the intervention at 30th day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition Profile | permits a detailed analysis of the body's major structural components like muscle mass, fat, and bone. It is measured in percentage. | Change from baseline at 30th Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Body mass index is a value derived from the mass and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m², resulting from mass in kilograms and height in metres | Change from Baseline at 30th Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cumin Seeds, Black seed, Obese grade I