Trial · NCT04852510
Amelioration of Polycystic Ovary Syndrome Related Disorders by Supplementation of Thymoquinone and Metformin
NCT04852510, Phase 2, Phase 3, Completed, Saudi German Hospital - Madinah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Amelioration of Polycystic Ovary Syndrome Related Disorders by Supplementation of Thymoquinone and Metformin. Trials, record NCT04852510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04852510
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Amelioration of Polycystic Ovary Syndrome Related Disorders by Supplementation of Thymoquinone and Metformin
- NCT number
- NCT04852510
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 253 participants, actual
- Lead sponsor
- Saudi German Hospital - Madinah
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Interventions
- Metformin Versus a combination of Metformin and Thymoquinone (TQ)
- First posted
- 2021-04-21
- Last updated
- 2021-04-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The change of menstrual cycle pattern. | At the beginning of the study, After 3 months and After 6 Months | Patients were asked about their menstrual cycle pattern (Frequency of menstrual cycles and number of days of menses). Resumption of normal menstrual cyclicity was defined as having menses every 3-5 weeks. Amenorrhea was defined as absence of menstruation for six or more months. Oligomenorrhea was defined as cycle interval of more than 35 days but less than 6 months. |
| Primary | The change of body mass index (BMI). | At the beginning of the study, After 3 months and After 6 Months | The body mass index is calculated as the body weight in kilograms divided by the height in meters squared. Normal BMI was defined as a range of 18.5-24.9 kg/m2. Overweight defined as body mass index (BMI) 25-29.9 kg/m2 and obesity defined as BMI ≥ 30 kg/m2. |
| Primary | Change of body fat distribution as proved by change of Waist/Hip ratio. | At the beginning of the study, After 3 months and After 6 Months | Waist circumference was measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest. Hip circumference was measured around the widest portion of the buttocks. For both measurements, the tape was adjusted parallel to the floor at the level at which the measurement was made. The tape was held snugly around the body, but not pulled so tight. The patient was standing with feet close together, arms at the sides and body weight evenly distributed across the feet. The waist circumference was measured at the end of a normal expiration, when the lungs are at their functional residual capacity. Each measurement was repeated twice; if the measurements were within 1 cm of one another, the average was calculated. If the difference between the two measurements exceeded 1 cm, the two measurements were repeated. |
| Primary | Change of oral glucose tolerance test (OGTT) results. | At the beginning of the study, After 3 months and After 6 Months | The oral glucose tolerance test (OGTT) was performed in the morning after an overnight fasting of at least 8 hours, utilizing a glucose load containing the equivalent of 75 grams of anhydrous glucose dissolved in water. Prediabetes was defined by the American Diabetes Association 2014 as those patients who have; impaired fasting glucose (IFG) defined as fasting plasma glucose (FPG) levels of 100 to 125 mg/dL (Fasting was described as no caloric intake for at least 8 hours), or impaired glucose tolerance (IGT) defined as 2-hour readings of 140 to 199 mg/dL in the oral glucose tolerance test (OGTT). Diabetes mellitus was defined According to the American Diabetes Association 2014, as FPG ≥ 126 mg/dL or 2-hour plasma glucose readings ≥ 200 mg/dL during 75 g OGTT. |
| Primary | Change of Glycosylated Hemoglobin A1C levels. | At the beginning of the study, After 3 months and After 6 Months | Glycosylated Hemoglobin A1C levels were measured as percentage (%) from the total hemoglobin. Normal range defined as readings below 5.7%. Prediabetes was defined by the American Diabetes Association 2014 as patients who have their Glycosylated Hemoglobin A1C levels between 5.7% and 6.4%. Diabetes mellitus was defined According to the American Diabetes Association 2014, as Glycosylated Hemoglobin A1C levels ≥ 6.5%. |
| Primary | Change of serum Malondialdehyde (MDA) concentrations. | At the beginning of the study, After 3 months and After 6 Months | Malondialdehyde (MDA) concentrations were measured in µmol/liter using the derivatization MDA with thiobarbituric acid (TBA) based on spectrophotometric determination of pink fluorescent MDA-TBA complex produced after reaction with 2-thiobarbituric acid at high temperature and low pH. The assay kits for MDA and SOD were products of (Cell Biolabs Inc, San Diego, USA). |
| Primary | Change of serum superoxide dismutase (SOD) activity. | At the beginning of the study, After 3 months and After 6 Months | For estimation of SOD activity, centrifugation of the blood samples was done at 1000 g for 10 minutes, the serum was frozen and stored at -80 °C until the time of analysis. SOD activity was based on the ability of the enzyme to inhibit the reduction of nitro blue tetrazolium dye mediated by phenazine methosulphate. The purified SOD inhibits the initial rate of reduction of (O2 to O2-) mediated by the activated phenazine methosulphate which then reduces the nitro blue tetrazolium. The percentage of inhibition was then calculated and compared to the standard of 0.5 μg of the enzyme that produced inhibition of 80 % (activity = 3.000 units/mg protein). The SOD activity was finally expressed as units of enzymatic activity per mg of protein contained in the samples (U/mg protein). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04852510
GET https://conductscience.org/api/trials/v1/NCT04852510/registered