Polycystic Ovary SyndromePCOS-COMBO (9)NCT07380841
Metformin vs Inositol vs Diet vs Combination Therapy in PCOS
A study testing Metformin Hydrochloride, Myo-Inositol and Dietary Restriction in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial summary
Polycystic ovary syndrome (PCOS) is a common condition that can cause irregular periods, excess male-type hormones, weight gain, and insulin resistance. This study will compare four commonly used approaches for PCOS management: metformin, inositol, a calorie-restricted diet, and a combination of all three. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance, Metabolic Syndrome
- What is being tested?
- Metformin Hydrochloride, Myo-Inositol and Dietary Restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 sitePakistan
- Study dates
- 21 May 2025to 13 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy or lactation. Known diabetes mellitus, thyroid disease, hyperprolactinemia, Cushing's syndrome, or other endocrine disorders.
- Use of metformin, inositol, hormonal therapy, or weight-loss drugs within the last 3 months.
- History of renal, hepatic, or cardiovascular disease. Known hypersensitivity to metformin or inositol. Participation in another clinical trial within the last 3 months. Any serious medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Health Sciences / Islamabad Medical and Dental College (IMDC)
Islamabad, Islamabad, 44000
About this study
Official title: Comparative Effectiveness of Metformin, Inositol, Dietary Restriction, and Combination Therapy in Polycystic Ovary Syndrome: A 12-Week Prospective Randomized Study
Polycystic ovary syndrome (PCOS) is a common condition that can cause irregular periods, excess male-type hormones, weight gain, and insulin resistance. This study will compare four commonly used approaches for PCOS management: metformin, inositol, a calorie-restricted diet, and a combination of all three.
A total of 192 women aged 18-35 years with PCOS (diagnosed using Rotterdam criteria) will be randomly assigned to one of four groups for 12 weeks: (A) metformin, (B) myo-inositol plus D-chiro-inositol, (C) calorie-restricted diet, or (D) combination therapy (metformin + inositol + diet). The study will assess changes in body weight, body mass index (BMI), waist circumference, fasting glucose, fasting insulin, insulin resistance (HOMA-IR), and menstrual regularity. Hormonal measures and safety outcomes will also be evaluated. The goal is to determine which approach provides the greatest overall metabolic and reproductive benefit in women with PCOS.
Read the detailed description
This is a 12-week, prospective, randomized, parallel-group controlled clinical trial conducted at an academic tertiary-care center in Islamabad, Pakistan (July-October 2025). The trial compares the independent and combined effects of metformin, inositol, and calorie restriction on metabolic, anthropometric, hormonal, and reproductive outcomes in women with polycystic ovary syndrome (PCOS).
Participants A total of 192 reproductive-aged women (18-35 years) with PCOS diagnosed by Rotterdam criteria (≥2 of: oligo/anovulation, clinical/biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound) will be enrolled. Key exclusions include thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing syndrome, hepatic/renal impairment, pregnancy or lactation, and use of hormonal therapy or insulin-sensitizing agents within the preceding 3 months.
Randomization and masking Participants will be randomized in a 1:1:1:1 allocation (n=48 per group) using a computer-generated sequence, with allocation concealment using sequentially numbered, opaque, sealed envelopes. Due to the nature of interventions, participant blinding is not feasible; however, laboratory personnel and data analysts will remain blinded to group assignment.
Interventions (12 weeks) Group A (Metformin): metformin 1500-2000 mg/day orally, titrated according to gastrointestinal tolerance.
Group B (Inositol): myo-inositol 2 g plus D-chiro-inositol 50 mg, taken twice daily.
Group C (Calorie-restricted diet): individualized dietary counseling targeting 1200-1500 kcal/day with emphasis on low-glycemic carbohydrates, lean protein, and high-fiber foods.
Group D (Combination): metformin + inositol + calorie-restricted diet as above. Participants will be followed every two weeks for adherence assessment and adverse event monitoring. Medication adherence will be assessed by pill counts. Dietary adherence will be assessed using weekly dietary logs and summarized as percent compliance with prescribed caloric intake.
Outcomes
Primary outcomes assessed at baseline and 12 weeks include:
Anthropometric measures: weight, BMI, waist circumference; Metabolic measures: fasting glucose, fasting insulin, and insulin resistance (HOMA-IR; calculated as [fasting insulin × fasting glucose]/405); Menstrual regularity, defined as cycle length 21-35 days during the final four weeks of the intervention.
Secondary outcomes include serum total testosterone, LH, FSH, LH/FSH ratio, Ferriman-Gallwey score, adherence, and adverse events. Fasting blood samples will be collected and hormonal assays performed using standardized chemiluminescence immunoassay platforms.
Statistical approach Normality will be assessed using Shapiro-Wilk tests. Continuous variables will be summarized as mean ± SD. Within-group changes will be analyzed using paired t-tests. Between-group comparisons will use one-way ANOVA with Tukey HSD post-hoc testing. Effect sizes will be reported as partial eta-squared (η²). Categorical outcomes (e.g., menstrual regularity) will be compared using chi-square tests. Statistical significance will be defined as p < 0.05. Analyses will follow CONSORT reporting principle
- Being tested
- Metformin Hydrochloride, Myo-Inositol, Dietary Restriction, Metformin + Myo-inositol + Dietary Restriction
- Keywords
- PCOS, Metformin, Myo-inositol, Dietary Restriction, Insulin Resistance, Weight Loss, Combination Therapy
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin HydrochlorideDrug
Also called Glucophage
Metformin is an insulin-sensitizing biguanide used to improve glucose metabolism and reduce insulin resistance in women with polycystic ovary syndrome. It is administered orally as part of the study protocol to evaluate its effects on metabolic, hormonal, and reproductive outcomes.
Myo-InositolDietary supplement
Also called Inositol, Vitamin B8
Myo-inositol is a nutritional supplement involved in insulin signaling pathways and ovarian function. It is used in this study to assess its effect on insulin sensitivity, hormonal profile, and clinical features of polycystic ovary syndrome.
Dietary RestrictionBehavioural
Also called Calorie-restricted diet, Weight Reduction Diet
A structured, supervised calorie-restricted dietary program is used as a lifestyle intervention to improve weight, metabolic parameters, and reproductive function in women with polycystic ovary syndrome.
Metformin + Myo-inositol + Dietary RestrictionCombination product
Also called Combined lifestyle and pharmacological intervention
This intervention combines pharmacological insulin sensitization and nutritional supplementation with lifestyle modification to evaluate the synergistic effect on metabolic, hormonal, and clinical outcomes in women with polycystic ovary syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Metformin Group | Experimental | Participants will receive metformin hydrochloride tablets, 500 mg orally twice daily (total daily dose 1000 mg) after meals for 12 weeks. This arm evaluates the effect of metformin monotherapy on metabolic, hormonal, and clinical outcomes in women with polycystic ovary syndrome (PCOS). Receives: Drug: Metformin Hydrochloride |
| Inositol Group | Experimental | Participants will receive myo-inositol powder/sachets, 2 g orally twice daily (total daily dose 4 g) for 12 weeks. This arm evaluates the effect of inositol monotherapy on insulin resistance, hormonal profile, and clinical features of PCOS. Receives: Dietary Supplement: Myo-Inositol |
| Dietary Restriction Group | Experimental | Participants will follow a structured calorie-restricted diet (approximately 1200-1500 kcal/day, individualized according to baseline BMI), designed and supervised by the study team, for 12 weeks. No pharmacological treatment will be given. This arm evaluates the effect of dietary intervention alone on anthropometric, metabolic, and reproductive outcomes in PCOS. Receives: Behavioral: Dietary Restriction |
| Combination Therapy Group | Experimental | Participants will receive metformin hydrochloride tablets 500 mg orally twice daily plus myo-inositol 2 g orally twice daily, along with the same structured calorie-restricted diet (1200-1500 kcal/day) for 12 weeks. This arm evaluates the combined effect of pharmacological and lifestyle intervention on metabolic, hormonal, and clinical outcomes in PCOS. Receives: Combination Product: Metformin + Myo-inositol + Dietary Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin resistance (HOMA-IR)
Mean change in insulin resistance as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting serum insulin levels, comparing baseline values to 12-week follow-up among the four treatment groups (metformin, inositol, dietary restriction, and combination therapy).
Measured: Baseline to 12 weeks
Secondary outcomes (3)
Change in body weight and body mass index (BMI)
Mean change in body weight (kg) and body mass index (kg/m²) from baseline to 12 weeks.
Measured: Baseline to 12 weeks
Change in menstrual cycle regularity
Proportion of participants achieving regular menstrual cycles or improvement in cycle regularity over the 12-week intervention period.Baseline to 12 weeks
Measured: Baseline to 12 weeks
Change in serum androgen levels
Mean change in serum total testosterone levels from baseline to 12 weeks
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start21 May 2025
- Primary completion11 Nov 2025
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four-arm, randomized, parallel-group comparative trial.
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shemaila Saleem, Study director, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380841
- Sponsor's protocol ID
- PCOS-MIDCOMBO-12W-2025
- Other IDs
- F-1/2015/ERB/SZABMU/1449)
- Acronym
- PCOS-COMBO (9)
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including demographic, clinical, biochemical, and outcome variables, will be made available to qualified researchers upon reasonable request. Data will be shared in a de-identified format to protect participant confidentiality. Requests will be reviewed by the principal investigator and the institutional ethics committee.
Publications
Irfan NU, Saleem S, Irfan A. Multimodal Therapy With Metformin, Inositol and Dietary Restriction Improves Insulin Resistance and Endocrine Outcomes in Women With Polyendocrine Metabolic Ovarian Syndrome: A Randomized Controlled Trial. Clin Endocrinol (Oxf). 2026 Jul 28. doi: 10.1111/cen.70188. Online ahead of print.
PubMed 42517336
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Metformin, Inositol, Dietary Restriction, and Combination Therapy in Polycystic Ovary Syndrome: A 12-Week Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07380841
- Acronym / sponsor ID
- PCOS-COMBO (9) / PCOS-MIDCOMBO-12W-2025
- Keywords
- PCOS, Metformin, Myo-inositol, Dietary Restriction, Insulin Resistance, Weight Loss, Combination Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 11 Nov 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polycystic ovary syndrome (PCOS) is a common condition that can cause irregular periods, excess male-type hormones, weight gain, and insulin resistance. This study will compare four commonly used approaches for PCOS management: metformin, inositol, a calorie-restricted diet, and a combination of all three.
A total of 192 women aged 18-35 years with PCOS (diagnosed using Rotterdam criteria) will be randomly assigned to one of four groups for 12 weeks: (A) metformin, (B) myo-inositol plus D-chiro-inositol, (C) calorie-restricted diet, or (D) combination therapy (metformin + inositol + diet). The study will assess changes in body weight, body mass index (BMI), waist circumference, fasting glucose, fasting insulin, insulin resistance (HOMA-IR), and menstrual regularity. Hormonal measures and safety outcomes will also be evaluated. The goal is to determine which approach provides the greatest overall metabolic and reproductive benefit in women with PCOS.
Detailed description
This is a 12-week, prospective, randomized, parallel-group controlled clinical trial conducted at an academic tertiary-care center in Islamabad, Pakistan (July-October 2025). The trial compares the independent and combined effects of metformin, inositol, and calorie restriction on metabolic, anthropometric, hormonal, and reproductive outcomes in women with polycystic ovary syndrome (PCOS).
Participants A total of 192 reproductive-aged women (18-35 years) with PCOS diagnosed by Rotterdam criteria (≥2 of: oligo/anovulation, clinical/biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound) will be enrolled. Key exclusions include thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, Cushing syndrome, hepatic/renal impairment, pregnancy or lactation, and use of hormonal therapy or insulin-sensitizing agents within the preceding 3 months.
Randomization and masking Participants will be randomized in a 1:1:1:1 allocation (n=48 per group) using a computer-generated sequence, with allocation concealment using sequentially numbered, opaque, sealed envelopes. Due to the nature of interventions, participant blinding is not feasible; however, laboratory personnel and data analysts will remain blinded to group assignment.
Interventions (12 weeks) Group A (Metformin): metformin 1500-2000 mg/day orally, titrated according to gastrointestinal tolerance.
Group B (Inositol): myo-inositol 2 g plus D-chiro-inositol 50 mg, taken twice daily.
Group C (Calorie-restricted diet): individualized dietary counseling targeting 1200-1500 kcal/day with emphasis on low-glycemic carbohydrates, lean protein, and high-fiber foods.
Group D (Combination): metformin + inositol + calorie-restricted diet as above. Participants will be followed every two weeks for adherence assessment and adverse event monitoring. Medication adherence will be assessed by pill counts. Dietary adherence will be assessed using weekly dietary logs and summarized as percent compliance with prescribed caloric intake.
Outcomes
Primary outcomes assessed at baseline and 12 weeks include:
Anthropometric measures: weight, BMI, waist circumference; Metabolic measures: fasting glucose, fasting insulin, and insulin resistance (HOMA-IR; calculated as [fasting insulin × fasting glucose]/405); Menstrual regularity, defined as cycle length 21-35 days during the final four weeks of the intervention.
Secondary outcomes include serum total testosterone, LH, FSH, LH/FSH ratio, Ferriman-Gallwey score, adherence, and adverse events. Fasting blood samples will be collected and hormonal assays performed using standardized chemiluminescence immunoassay platforms.
Statistical approach Normality will be assessed using Shapiro-Wilk tests. Continuous variables will be summarized as mean ± SD. Within-group changes will be analyzed using paired t-tests. Between-group comparisons will use one-way ANOVA with Tukey HSD post-hoc testing. Effect sizes will be reported as partial eta-squared (η²). Categorical outcomes (e.g., menstrual regularity) will be compared using chi-square tests. Statistical significance will be defined as p < 0.05. Analyses will follow CONSORT reporting principle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four-arm, randomized, parallel-group comparative trial.
| Arm | Type | Receives |
|---|---|---|
| Metformin Group | Experimental | Drug: Metformin HydrochlorideParticipants will receive metformin hydrochloride tablets, 500 mg orally twice daily (total daily dose 1000 mg) after meals for 12 weeks. This arm evaluates the effect of metformin monotherapy on metabolic, hormonal, and clinical outcomes in women with polycystic ovary syndrome (PCOS). |
| Inositol Group | Experimental | Dietary Supplement: Myo-InositolParticipants will receive myo-inositol powder/sachets, 2 g orally twice daily (total daily dose 4 g) for 12 weeks. This arm evaluates the effect of inositol monotherapy on insulin resistance, hormonal profile, and clinical features of PCOS. |
| Dietary Restriction Group | Experimental | Behavioral: Dietary RestrictionParticipants will follow a structured calorie-restricted diet (approximately 1200-1500 kcal/day, individualized according to baseline BMI), designed and supervised by the study team, for 12 weeks. No pharmacological treatment will be given. This arm evaluates the effect of dietary intervention alone on anthropometric, metabolic, and reproductive outcomes in PCOS. |
| Combination Therapy Group | Experimental | Combination Product: Metformin + Myo-inositol + Dietary RestrictionParticipants will receive metformin hydrochloride tablets 500 mg orally twice daily plus myo-inositol 2 g orally twice daily, along with the same structured calorie-restricted diet (1200-1500 kcal/day) for 12 weeks. This arm evaluates the combined effect of pharmacological and lifestyle intervention on metabolic, hormonal, and clinical outcomes in PCOS. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Pregnancy or lactation. Known diabetes mellitus, thyroid disease, hyperprolactinemia, Cushing's syndrome, or other endocrine disorders.
- Use of metformin, inositol, hormonal therapy, or weight-loss drugs within the last 3 months.
- History of renal, hepatic, or cardiovascular disease. Known hypersensitivity to metformin or inositol. Participation in another clinical trial within the last 3 months. Any serious medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin HydrochlorideAlso: GlucophageMetformin is an insulin-sensitizing biguanide used to improve glucose metabolism and reduce insulin resistance in women with polycystic ovary syndrome. It is administered orally as part of the study protocol to evaluate its effects on metabolic, hormonal, and reproductive outcomes. | Drug | Metformin Group |
| Myo-InositolAlso: Inositol, Vitamin B8Myo-inositol is a nutritional supplement involved in insulin signaling pathways and ovarian function. It is used in this study to assess its effect on insulin sensitivity, hormonal profile, and clinical features of polycystic ovary syndrome. | Dietary supplement | Inositol Group |
| Dietary RestrictionAlso: Calorie-restricted diet, Weight Reduction DietA structured, supervised calorie-restricted dietary program is used as a lifestyle intervention to improve weight, metabolic parameters, and reproductive function in women with polycystic ovary syndrome. | Behavioural | Dietary Restriction Group |
| Metformin + Myo-inositol + Dietary RestrictionAlso: Combined lifestyle and pharmacological interventionThis intervention combines pharmacological insulin sensitization and nutritional supplementation with lifestyle modification to evaluate the synergistic effect on metabolic, hormonal, and clinical outcomes in women with polycystic ovary syndrome. | Combination product | Combination Therapy Group |
Primary outcome
Change in insulin resistance (HOMA-IR)
Time frame: Baseline to 12 weeks
Mean change in insulin resistance as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting serum insulin levels, comparing baseline values to 12-week follow-up among the four treatment groups (metformin, inositol, dietary restriction, and combination therapy).
3 secondary outcomes
Change in body weight and body mass index (BMI)
Time frame: Baseline to 12 weeks
Change in menstrual cycle regularity
Time frame: Baseline to 12 weeks
Change in serum androgen levels
Time frame: Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Derived from this study: PubMed 42517336Irfan NU, Saleem S, Irfan A. Multimodal Therapy With Metformin, Inositol and Dietary Restriction Improves Insulin Resistance and Endocrine Outcomes in Women With Polyendocrine Metabolic Ovarian Syndrome: A Randomized Controlled Trial. Clin Endocrinol (Oxf). 2026 Jul 28. doi: 10.1111/cen.70188. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study, including demographic, clinical, biochemical, and outcome variables, will be made available to qualified researchers upon reasonable request. Data will be shared in a de-identified format to protect participant confidentiality. Requests will be reviewed by the principal investigator and the institutional ethics committee.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shemaila Saleem study director
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metformin Hydrochloride, Myo-Inositol and Dietary Restriction in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Islamabad Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin resistance (HOMA-IR) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07380841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.