Comparative StudyPhase 1NCT06199544
Effect of Unani Medicine for the Management of Anomalies Associated With Polycystic Ovarian Syndrome
A Phase 1 study testing Metformin in people with Comparative Study, run by Hamdard University at 1 site in Pakistan.
Trial summary
Currently available medications for PCOS are symptom(s) oriented but have limitations because of its complex pathophysiology. The most preferred drug against PCOS is metformin which act as an insulin sensitizer to improve insulin-glucose metabolism and anovulatory cycles in PCOS. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Comparative Study
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 1 Dec 2024
- Phase
- Phase 1
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 1) Patients with severe adverse drug reactions, 2) Record of cardiovascular, diabetes, hepatic and neoplastic disorders or other concurrent medical illnesses, 3) Hormonal contraceptive used within 6 months, or anti-obesity drugs within 3 months of the study, 4) Irregular menstrual bleeding other than PCOS and 5) Positive pregnancy test.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa ul mulk memorial hospital
Karachi, Sindh
Noman Khan, PhD, 03453161306, nomankhan007@hotmail.com
About this study
Official title: Effect of Unani Medicine Coded Formulations for the Management of Anomalies Associated With Polycystic Ovarian Syndrome
Currently available medications for PCOS are symptom(s) oriented but have limitations because of its complex pathophysiology. The most preferred drug against PCOS is metformin which act as an insulin sensitizer to improve insulin-glucose metabolism and anovulatory cycles in PCOS. However, its use is associated with various side effects such as bloating, diarrhea and nausea. Thus, it is imperative to explore various other alternatives to combat this gynecological problem.
Read the detailed description
Polycystic ovarian syndrome (PCOS) is a common endocrine disorder in reproductive age women, with a prevalence between 5%-15%. Currently, sedentary lifestyle, excessive intake of junk food and increasing prevalence of obesity has been associated with rise in the incidence of PCOS.
- Conditions
- Comparative Study
- Being tested
- Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Picolin, Rasoline
Comparing the effect of drugs on symptoms of PCOS
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | metformin 500 mg twice a day Receives: Drug: Metformin |
| Picolin group | Experimental | Picolin 500mg thrice a day Receives: Drug: Metformin |
| Rasoline | Experimental | Rasoline 500mg thrice a day Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in the menstrual regularity of the patient
The lengths and duration of menstrual cycle of patients will be measured
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Oct 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative StudyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leena Hameed, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199544
- Sponsor's protocol ID
- HamdardUniversity
- Status last verified
- Dec 2023
- First submitted
- 29 Jan 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Unani Medicine Coded Formulations for the Management of Anomalies Associated With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT06199544
- Acronym / sponsor ID
- HamdardUniversity
- Conditions
- Comparative Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
Currently available medications for PCOS are symptom(s) oriented but have limitations because of its complex pathophysiology. The most preferred drug against PCOS is metformin which act as an insulin sensitizer to improve insulin-glucose metabolism and anovulatory cycles in PCOS. However, its use is associated with various side effects such as bloating, diarrhea and nausea. Thus, it is imperative to explore various other alternatives to combat this gynecological problem.
Detailed description
Polycystic ovarian syndrome (PCOS) is a common endocrine disorder in reproductive age women, with a prevalence between 5%-15%. Currently, sedentary lifestyle, excessive intake of junk food and increasing prevalence of obesity has been associated with rise in the incidence of PCOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: Metforminmetformin 500 mg twice a day |
| Picolin group | Experimental | Drug: MetforminPicolin 500mg thrice a day |
| Rasoline | Experimental | Drug: MetforminRasoline 500mg thrice a day |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1) Patients with severe adverse drug reactions, 2) Record of cardiovascular, diabetes, hepatic and neoplastic disorders or other concurrent medical illnesses, 3) Hormonal contraceptive used within 6 months, or anti-obesity drugs within 3 months of the study, 4) Irregular menstrual bleeding other than PCOS and 5) Positive pregnancy test.
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 |
|---|---|---|
| MetforminAlso: Picolin, RasolineComparing the effect of drugs on symptoms of PCOS | Drug | Control group, Picolin group, Rasoline |
Primary outcome
Improvement in the menstrual regularity of the patient
Time frame: 1 year
The lengths and duration of menstrual cycle of patients will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin in people with Comparative Study, run by Hamdard University 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 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leena Hameed, M.Phil. (00923333037145, Leena.hameed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in the menstrual regularity of the patient (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2024.