Diabetes Type 2Phase 3NCT07279909
Phase-III Clinical Studies on Poly Herbal Anti-Diabetic Formulation
A Phase 3 study testing DIAB-PHC1 and Metformin in people with Diabetes Type 2 and Diabetes Mellitus, Experimental, run by Hamdard University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Type 2, Diabetes Mellitus, Experimental, HbA1c
- What is being tested?
- DIAB-PHC1 and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2024to 20 May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having Type II Diabetes Mellitus.
- Patients agree willingly to use study medicine throughout the study
- Patients having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
- Patients over 30 years of age.
- Patients of both genders will be included in the study.
Who cannot join
- Patients who do not agree willingly to participate in research.
- Patients having history of any chronic organ failure.
- Patients having history of any amputation.
- Patients having history of treated or diagnosed cancer of any organ.
- Pregnant and lactating mothers.
- Patients who are having brittle Diabetes
- Known under treatment cases of psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Clinical & Clinical Studies on Poly Herbal Anti-Diabetic Formulation
The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. The main question that aims to search is
- Does the herbal combination formula effective to lower the high blood glucose levels in Type2 diabetics
- Is the herbal combination therapy is safe for human use
- Does this treatment plan reduces the blood sugar level comparative to Metformin 500 mg TID The trial is also comparing its efficacy in comparison to a standard anti diabetic drug Metformin In the study wing, the volunteer diabetic patients will take the herbal capsule 500mg TID and in the control group the volunteer patients will take Metformin 500 mg TID.
- The recruited patients will continue the assigned therapy for at least six months
- They visit the clinical trial OPDs fortnightly
- They will record their fasting blood glucose with the glucometer at least two to three times a week and get the basal tests done in three-month time
Read the detailed description
Preclinical evaluation studies including stability, dissolution and anti-microbial testing were performed. The formulation was also subjected to gas chromatography-mass spectrometry (GCMS). The powdered formulation was analyzed for LD-50 followed by two-center, unblinded, non-randomized controlled clinical trial with convenient sampling was conducted over 24 weeks in 500 adults with T2DM (HbA1c 7.5-10%). Participants were assigned to receive either polyherbal capsules (~500 mg three times daily, n = 250) or metformin (500 mg three times daily, n = 250). Primary outcome was HbA1c reduction; secondary outcomes included fasting/postprandial glucose, urinary protein, urinary glucose, lipid profile, body weight, and safety. Statistical analyses were performed using two-way ANOVA and unpaired t-tests.
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Experimental, HbA1c, Urinary Glucose, Ability of Experimental Drug to Lower HbA1c Compare to Metformin
- Being tested
- DIAB-PHC1, Metformin
- Keywords
- Polyherbal formulation, GCMS, Syzygium cumini, Momordica charantia, Wrightia tinctoria,, Gymnema sylvestre,
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAB-PHC1Drug
a novel poly-herbal hard gelatin capsule formulation comprising Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in a scientifically optimized ratio. Although each of these herbs is traditionally recognized for its individual anti-diabetic activity, their combination in a standardized dosage form has not previously been reported.
The study further strengthens its novelty by conducting comprehensive pre-clinical safety evaluations, confirming the absence of toxicity before proceeding to controlled clinical investigations.
MetforminDrug
Also called Glucophage
Standard oral hypoglycemic comparator
| Study group | Role | What they receive |
|---|---|---|
| Metformin - control are of the study | Active comparator | Metformin is standardized hypoglycemic agent with global accepted efficacy \& safety Receives: Drug: Metformin |
| DIAB-PHC1 - Treatment arm of the study | Experimental | The investigational formulation consisted of Syzygium cumini, Momordica charantia, Wrightia tinctoria and Gymnema sylvestre. Raw plant materials were procured from local herbal markets and authenticated shade dried and powdered. The powder was capsulated with avverage weight of 500 mg /capsule. Capsules were given TID with meals to the patients Receives: Drug: DIAB-PHC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin (HbA1c)
The primary objective is to assess improvements in glycated hemoglobin (HbA1c) and fasting/ post-prandial plasma glucose.
Measured: From two weeks to six months time period
Secondary outcomes (2)
Urinary Proteins
The secondary objectives are to evaluate reduction in the amount of proteins in urine
Measured: At least Six months
Urinary Glucose
regular check for the urinary glucose levels as a parameter for improved glycemic control
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start9 Mar 2024
- Primary completion1 Aug 2025
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized control trial. Two study arms. Test drug (polyherbal drug) and control group. Treatment in the both arms for 6 months at-least. Follow-up every 15 days. Revise clinical investigations of HbA1c, Urinary proteins and glucose
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre
- Responsible party
- Principal investigator, Abdul Bari, Hamdard University
- Investigators
- Mehboob Alam, PhD, Study director, Department of Pharmacology, Institute of Basic Medical Sciences, JPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279909
- Sponsor's protocol ID
- DIAB-PHC1
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to keep the privacy \& anonymity of the individual participant of the study, as committed at the time of induction
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Clinical & Clinical Studies on Poly Herbal Anti-Diabetic Formulation
- ClinicalTrials.gov ID
- NCT07279909
- Acronym / sponsor ID
- DIAB-PHC1
- Conditions
- Diabetes Type 2, Diabetes Mellitus, Experimental, HbA1c, Urinary Glucose, Ability of Experimental Drug to Lower HbA1c Compare to Metformin
- Keywords
- Polyherbal formulation, GCMS, Syzygium cumini, Momordica charantia, Wrightia tinctoria,, Gymnema sylvestre,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Collaborators
- Jinnah Postgraduate Medical Centre
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 12 Dec 2025 (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.
The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. The main question that aims to search is
- Does the herbal combination formula effective to lower the high blood glucose levels in Type2 diabetics
- Is the herbal combination therapy is safe for human use
- Does this treatment plan reduces the blood sugar level comparative to Metformin 500 mg TID The trial is also comparing its efficacy in comparison to a standard anti diabetic drug Metformin In the study wing, the volunteer diabetic patients will take the herbal capsule 500mg TID and in the control group the volunteer patients will take Metformin 500 mg TID.
- The recruited patients will continue the assigned therapy for at least six months
- They visit the clinical trial OPDs fortnightly
- They will record their fasting blood glucose with the glucometer at least two to three times a week and get the basal tests done in three-month time
Detailed description
Preclinical evaluation studies including stability, dissolution and anti-microbial testing were performed. The formulation was also subjected to gas chromatography-mass spectrometry (GCMS). The powdered formulation was analyzed for LD-50 followed by two-center, unblinded, non-randomized controlled clinical trial with convenient sampling was conducted over 24 weeks in 500 adults with T2DM (HbA1c 7.5-10%). Participants were assigned to receive either polyherbal capsules (~500 mg three times daily, n = 250) or metformin (500 mg three times daily, n = 250). Primary outcome was HbA1c reduction; secondary outcomes included fasting/postprandial glucose, urinary protein, urinary glucose, lipid profile, body weight, and safety. Statistical analyses were performed using two-way ANOVA and unpaired t-tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized control trial. Two study arms. Test drug (polyherbal drug) and control group. Treatment in the both arms for 6 months at-least. Follow-up every 15 days. Revise clinical investigations of HbA1c, Urinary proteins and glucose
| Arm | Type | Receives |
|---|---|---|
| Metformin - control are of the study | Active comparator | Drug: MetforminMetformin is standardized hypoglycemic agent with global accepted efficacy \& safety |
| DIAB-PHC1 - Treatment arm of the study | Experimental | Drug: DIAB-PHC1The investigational formulation consisted of Syzygium cumini, Momordica charantia, Wrightia tinctoria and Gymnema sylvestre. Raw plant materials were procured from local herbal markets and authenticated shade dried and powdered. The powder was capsulated with avverage weight of 500 mg /capsule. Capsules were given TID with meals to the patients |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients having Type II Diabetes Mellitus.
- Patients agree willingly to use study medicine throughout the study
- Patients having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
- Patients over 30 years of age.
- Patients of both genders will be included in the study.
Key exclusion criteria (7 listed)
- Patients who do not agree willingly to participate in research.
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 |
|---|---|---|
| DIAB-PHC1a novel poly-herbal hard gelatin capsule formulation comprising Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in a scientifically optimized ratio. Although each of these herbs is traditionally recognized for its individual anti-diabetic activity, their combination in a standardized dosage form has not previously been reported. The study further strengthens its novelty by conducting comprehensive pre-clinical safety evaluations, confirming the absence of toxicity before proceeding to controlled clinical investigations. | Drug | DIAB-PHC1 - Treatment arm of the study |
| MetforminAlso: GlucophageStandard oral hypoglycemic comparator | Drug | Metformin - control are of the study |
Primary outcome
glycated hemoglobin (HbA1c)
Time frame: From two weeks to six months time period
The primary objective is to assess improvements in glycated hemoglobin (HbA1c) and fasting/ post-prandial plasma glucose.
2 secondary outcomes
Urinary Proteins
Time frame: At least Six months
Urinary Glucose
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. to keep the privacy \& anonymity of the individual participant of the study, as committed at the time of induction
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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.
Mehboob Alam, PhD study director
Department of Pharmacology, Institute of Basic Medical Sciences, JPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DIAB-PHC1 and Metformin in people with Diabetes Type 2 and Diabetes Mellitus, Experimental, 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
glycated hemoglobin (HbA1c) (time frame: From two weeks to six months time period). 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 12 Dec 2025.