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

Obese Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770791
• Other study ID #: ZaraYameen001-23
• Status: Recruiting
• Phase: Phase 1
• Start date: January 27, 2023
• Est. completion date: June 2023

Study information

• Verified date: February 2023
• Source: Sehat Medical Complex
• Contact: Imran Ghafoor
• Phone: 03344292887
• Email: imran.ghafoor64[@]gamil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Obesity

Intervention

Dietary Supplement:
• Black Seed ( Nigella Sativa)
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
• Cumin Seed (Cuminum Cyminum)
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

Locations

Country	Name	City	State
Pakistan	Sehat Medical Complex, Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Sehat Medical Complex

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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