Diabetes MellitusNCT06841497
Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II
A study testing Dolabi in people with Diabetes Mellitus and Type 2 DM, run by Hamdard University at 1 site in Pakistan.
Trial summary
Diabetes is a chronic health condition that affects millions of people worldwide. In recent years, Pakistan has witnessed a significant increase in the prevalence of diabetes, making it a major public health concern. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 DM
- What is being tested?
- Dolabi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jul 2024to 3 Oct 2025
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects having Type II Diabetes Mellitus.
- Subjects having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
- Subjects over 30 years of age.
- Subjects agree to use study medicine throughout the study.
Who cannot join
- Subjects suffering from chronic liver diseases and kidney failure.
- Subjects currently taking any hypoglycemic agent(s).
- Subjects suffering from any type of cancer and any other comorbid condition.
- Subjects having history of adverse drug reaction.
- Pregnant and Lactating mother.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shifa Ul Mulk Memorial Hospital-Hamdard University
Karachi, Sindh, 74600
About this study
Diabetes is a chronic health condition that affects millions of people worldwide. In recent years, Pakistan has witnessed a significant increase in the prevalence of diabetes, making it a major public health concern. To address this growing problem, conducting clinical trials on diabetes in Pakistan is of utmost importance. Clinical trials play a crucial role in advancing medical knowledge, improving patient care, and finding effective treatments for diabetes.
This research aims to assess the safety and effectiveness of the Unani formulation Dolabi in treating type II diabetes mellitus. The study consists of two phases: a pre-clinical phase, which involves acute and subacute oral toxicity testing on animal models, and a clinical phase, which includes a single-blind, single-arm, multicenter, phase II clinical trial conducted at Shifa ul Mulk Memorial Hospital-Hamdard University and Haidery Herbal Care-North Nazimabad to evaluate its clinical efficacy.
Read more
Diabetes management plays a vital role in effectively controlling the disease and minimizing its complications. Lifestyle management plays significant role in managing blood glucose levels in all age and gender segments. Medications are prescribed to regulate blood glucose levels when lifestyle changes alone are insufficient. Regular monitoring of blood sugar levels, along with other important parameters like blood pressure and cholesterol, helps individuals with diabetes to track their progress and make necessary adjustments to their treatment plans.
Dolabi is a time tested formulation of HLWP and it is being used clinically for more than 05 years at Hamdard Matabs all around Pakistan and clinically found satisfactory. The current study is designed in accordance with ICH GCP E6 protocols as approved by WHO and DRAP. It will enable us to present this safer and locally produced combination for the large community suffering with this condition in improving their lives.
- Conditions
- Diabetes Mellitus, Type 2 DM
- Being tested
- Dolabi
- Keywords
- Diabetes Mellitus, T2DM, Metabolic disease, Insulin Resistance
- Medical subject headings
- Diabetes Mellitus, Metabolic Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DolabiOther
herbal remedy for DM II
| Study group | Role | What they receive |
|---|---|---|
| Effect of Dolabi on DM II | Experimental | Not described Receives: Other: Dolabi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Sugars
Fasting Blood sugars at baseline and the end of treatment will be assess in (mg/dl).
Measured: 12 weeks
HbA1C (Glycosylated Hemoglobin)
Monitoring of HbA1C at baseline and at the end of treatment. the values of HbA1C will be assess in percentage (%).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start4 Jul 2024
- Primary completion4 Jul 2025 (estimated)
- Study completion3 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Bari, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841497
- Sponsor's protocol ID
- DLB-PII-HLWP
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II
- ClinicalTrials.gov ID
- NCT06841497
- Acronym / sponsor ID
- DLB-PII-HLWP
- Conditions
- Diabetes Mellitus, Type 2 DM
- Keywords
- Diabetes Mellitus, T2DM, Metabolic disease, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 4 Jul 2025 (estimated)
- Study completion
- 3 Oct 2025 (estimated)
- First posted
- 24 Feb 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.
Diabetes is a chronic health condition that affects millions of people worldwide. In recent years, Pakistan has witnessed a significant increase in the prevalence of diabetes, making it a major public health concern. To address this growing problem, conducting clinical trials on diabetes in Pakistan is of utmost importance. Clinical trials play a crucial role in advancing medical knowledge, improving patient care, and finding effective treatments for diabetes.
This research aims to assess the safety and effectiveness of the Unani formulation Dolabi in treating type II diabetes mellitus. The study consists of two phases: a pre-clinical phase, which involves acute and subacute oral toxicity testing on animal models, and a clinical phase, which includes a single-blind, single-arm, multicenter, phase II clinical trial conducted at Shifa ul Mulk Memorial Hospital-Hamdard University and Haidery Herbal Care-North Nazimabad to evaluate its clinical efficacy.
Diabetes management plays a vital role in effectively controlling the disease and minimizing its complications. Lifestyle management plays significant role in managing blood glucose levels in all age and gender segments. Medications are prescribed to regulate blood glucose levels when lifestyle changes alone are insufficient. Regular monitoring of blood sugar levels, along with other important parameters like blood pressure and cholesterol, helps individuals with diabetes to track their progress and make necessary adjustments to their treatment plans.
Dolabi is a time tested formulation of HLWP and it is being used clinically for more than 05 years at Hamdard Matabs all around Pakistan and clinically found satisfactory. The current study is designed in accordance with ICH GCP E6 protocols as approved by WHO and DRAP. It will enable us to present this safer and locally produced combination for the large community suffering with this condition in improving their lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of Dolabi on DM II | Experimental | Other: Dolabi |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects having Type II Diabetes Mellitus.
- Subjects having raised FBS above 120 mg/dl and HbA1C level 6.7 or above.
- Subjects over 30 years of age.
- Subjects agree to use study medicine throughout the study.
Key exclusion criteria (5 listed)
- Subjects suffering from chronic liver diseases and kidney failure.
- Subjects currently taking any hypoglycemic agent(s).
- Subjects suffering from any type of cancer and any other comorbid condition.
- Subjects having history of adverse drug reaction.
- Pregnant and Lactating mother.
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 |
|---|---|---|
| Dolabiherbal remedy for DM II | Other | Effect of Dolabi on DM II |
Primary outcome
Blood Sugars
Time frame: 12 weeks
Fasting Blood sugars at baseline and the end of treatment will be assess in (mg/dl).
HbA1C (Glycosylated Hemoglobin)
Time frame: 12 weeks
Monitoring of HbA1C at baseline and at the end of treatment. the values of HbA1C will be assess in percentage (%).
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 24 Feb 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dolabi in people with Diabetes Mellitus and Type 2 DM, 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 4 inclusion and 5 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 24 Feb 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.
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?
Blood Sugars (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 24 Feb 2025.