Comparative Effects of Using Black Seed and Cumin Seed on BCP of Obese Grade I
Primary Purpose
Obese
Status
Recruiting
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Black Seed ( Nigella Sativa)
Cumin Seed (Cuminum Cyminum)
Sponsored by
About this trial
This is an interventional health services research trial for Obese focused on measuring Cumin Seeds, Black seed, Obese grade I
Eligibility Criteria
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
Sites / Locations
- Sehat Medical Complex, LahoreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Group A Obese Grade I
Group B Obese Grade I
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05770791
First Posted
February 19, 2023
Last Updated
March 14, 2023
Sponsor
Sehat Medical Complex
1. Study Identification
Unique Protocol Identification Number
NCT05770791
Brief Title
Comparative Effects of Using Black Seed and Cumin Seed on BCP of Obese Grade I
Official Title
Comparative Effects of Using Black Seed (Nigella Sativa) and Cumin Seed ( Cuminum Cyminum) on Body Composition Profile of Obese Grade I
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese
Keywords
Cumin Seeds, Black seed, Obese grade I
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A Obese Grade I
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B Obese Grade I
Intervention Type
Dietary Supplement
Intervention Name(s)
Black Seed ( Nigella Sativa)
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Cumin Seed (Cuminum Cyminum)
Intervention Description
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
Primary Outcome Measure Information:
Title
Body Composition Profile
Description
permits a detailed analysis of the body's major structural components like muscle mass, fat, and bone. It is measured in percentage.
Time Frame
Change from baseline at 30th Day
Secondary Outcome Measure Information:
Title
BMI
Description
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
Time Frame
Change from Baseline at 30th Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Ghafoor
Phone
03344292887
Email
imran.ghafoor64@gamil.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momina Mehmood
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waseem Javaid
Phone
04235410037
Email
info.hw@smc.uol.edu.pk
12. IPD Sharing Statement
Learn more about this trial
Comparative Effects of Using Black Seed and Cumin Seed on BCP of Obese Grade I
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