NCT01360957

Brief Summary

The purpose of this clinical trial is to study the therapeutic effect of black cumin water extract (Nigella sativa L.) on obesity and overweight

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 18, 2015

Status Verified

February 1, 2011

First QC Date

May 24, 2011

Last Update Submit

November 17, 2015

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (8)

  • BP (blood pressure)

    Change from Baseline in Systolic Blood Pressure at 12 weeks

    0 and12 weeks

  • HR (heart rate)

    Change from Baseline in heart rate at 12 weeks

    0 and 12 weeks

  • Body water (percentage)

    Change from Baseline in body water at 12 weeks

    0 and 12 weeks

  • Fat free mass (percentage)

    Change from Baseline in fat free mass at 12 weeks

    0 and 12 weeks

  • Fat mass (percentage)

    Change from Baseline in fat mass at 12 weeks

    0 and 12 weeks

  • Bone mass

    Change from Baseline in bone mass at 12 weeks

    0 and 12 weeks

  • BMR (basic metabolic rate)

    Change from Baseline in BMR at 12 weeks

    0 and12 weeks

  • AMR (active metabolic rate)

    Change from Baseline in AMR at 12 weeks

    0 and 12 weeks

Secondary Outcomes (5)

  • BMI (body mass index)

    0 and 12 weeks

  • WHR (waist to hip ratio)

    0 and 12 weeks

  • MUAC (mid upper arm circumference)

    0 and 12 weeks

  • Wrist circumference

    0 and 12 weeks

  • Changes in appetite as measured by a 10-point visual analog scale (VAS)

    0 and 12 weeks

Study Arms (2)

Water flavored placebo

PLACEBO COMPARATOR

to be given orally in a dosage of 30 ml trice daily for 60 days

Dietary Supplement: Black cumin water extract as a traditional medicine

Black cumin water extract as a traditional medicine

EXPERIMENTAL

Black cumin water extract as a traditional medicine to be given orally in a dosage of 30 ml trice daily for 60 days

Dietary Supplement: Black cumin water extract as a traditional medicine

Interventions

Black cumin water extract as a traditional medicineDIETARY_SUPPLEMENT

to be given orally in a dosage of 30 ml trice daily for 60 days

Black cumin water extract as a traditional medicineWater flavored placebo

Eligibility Criteria

Age16 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being Obese

You may not qualify if:

  • Having heart disease or renal disease
  • using drugs influencing metabolism and appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Completion

June 1, 2011

Last Updated

November 18, 2015

Record last verified: 2011-02