NCT05770791

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

February 19, 2023

Last Update Submit

March 14, 2023

Conditions

Obese

Keywords

Cumin SeedsBlack seedObese grade I

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • BMI

    Change from Baseline at 30th Day

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A Obese Grade I

Dietary Supplement: Black Seed ( Nigella Sativa)

Group B

ACTIVE COMPARATOR

Group B Obese Grade I

Dietary Supplement: Cumin Seed (Cuminum Cyminum)

Interventions

Black Seed ( Nigella Sativa)DIETARY_SUPPLEMENT

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

Group A
Cumin Seed (Cuminum Cyminum)DIETARY_SUPPLEMENT

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

Group B

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject having BMI between 30 kg/m2 - 34.5 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Momina Mehmood

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Ghafoor

CONTACT

03344292887imran.ghafoor64@gamil.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

February 19, 2023

First Posted

March 15, 2023

Study Start

January 27, 2023

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-02

Locations

PA(1)