Trial · NCT07399535
Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
NCT07399535, Phase 1, Completed, Jinnah Postgraduate Medical Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome. Trials, record NCT07399535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07399535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Investigation of Herbal Formulation and Its Efficacy in Polycystic Ovarian Syndrome
- NCT number
- NCT07399535
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 116 participants, actual
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Conditions
- Polycystic Ovarian Syndrome (PCOS), Herbal Medicine, Infertility, Metabolic Disorder
- Interventions
- Herbal Formulation, Metformin XR, Metformin 750 mg and herbal formulation 500 mg
- First posted
- 2026-02-10
- Last updated
- 2026-06-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Regulation of Menstrual Cycle | Baseline to 4 months | Improvement and restoration of regular ovulatory menstrual cycles ( cycle length 21-35 days) after 4 months of treatment, assessed through menstrual history and ultrasonographic confirmation of ovulation. Ovulation confirmed by transvaginal ultrasonography, defined by the presence of a dominant follicle followed by follicular rupture during the treatment period. |
| Secondary | Serum Follicle-Stimulating Hormone (FSH) Levels | Baseline and after 4 months | Change in serum follicle-stimulating hormone (FSH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 3.5 - 12.5 , Women (Ovulation Phase): 4.7 - 21.5, Women (Luteal Phase): 1.7 - 7.7 |
| Secondary | Serum Luteinizing Hormone (LH) Levels | Baseline and after 4 months | Change in serum luteinizing hormone (LH) concentration measured using standard laboratory assays. Unit of Measure: mIU/mL, Normal Range: Women (Follicular Phase): 1.9 - 9.2, Women (Ovulation Phase): 6.1 - 49.1, Women (Luteal Phase): 1.3 - 10.8 |
| Secondary | Serum Testosterone Levels | Baseline and after 4 months | Change in serum testosterone levels measured using standard laboratory assays. Unit of Measure: ng/mL, Normal Range: 18-49 years: 0.084-0.481 |
| Secondary | Glycated Hemoglobin (HbA1c) Level | Baseline and after 4 months | Change in glycated hemoglobin (HbA1c) percentage measured using standardized laboratory methods. Unit of Measure: %, Normal Range: Normal \<5.6%, Prediabetes: 5.7% - 6.4%, Diabetes: 6.5% or higher |
| Secondary | Fasting Serum Insulin Concentration | Baseline and after 4 months | Change in fasting serum insulin concentration measured using standard laboratory assays. Unit of Measure: µIU/mL, Normal Range: 2 to 25 |
| Secondary | HOMA-IR | Before and after 4 months | HOMA-IR will be calculated before and immediately after 90-day treatment. HOMA-IR is calculated using the following equation: HOMA-IR = fasting plasma glucose in mmol/L×fasting insulin in μU/ml/22.5. |
| Secondary | Body Weight | Baseline and after 4 months | Change in body weight measured using a calibrated weighing scale. Unit of Measure: kg |
| Other | Assessment of quality of life via Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL) | Before and after 4 months | The Polycystic Ovary Syndrome Quality of Life Scale (PCOSQOL) is a disease-specific questionnaire used to assess the impact of polycystic ovary syndrome on quality of life. It evaluates five domains: Emotions (8 items), Body Hair (5 items), Weight (5 items), Infertility Problems (4 items), and Menstrual Problems (4 items). Cronbach's alpha were above 0.7 when the PCOSQL was validated (Jones et al., 2004). It has 26 items and uses a 7-point Likert-type scale. Scale Range: Minimum value: 1 Maximum value: 7 Lower scores indicate decreased quality of life, while higher scores indicate improved quality of life. |
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.
Papers18
The papers the trial lists on ClinicalTrials.gov.
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/NCT07399535
GET https://conductscience.org/api/trials/v1/NCT07399535/registered