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NCT06841497
Safety and Efficacy Assessment of Unani Formulation 'Dolabi' in Management of Diabetes Mellitus Type II
NA trial testing Dolabi in Diabetes Mellitus in 100 participants. Participants enrolled and being followed up; not accepting new ones.
4 July 2025
Quick facts
| Lead sponsor | Hamdard University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 4 July 2024 |
| Primary completion | 4 July 2025 |
| Estimated completion | 3 October 2025 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Dolabi
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Type 2 DM — all drugs for Type 2 DM →
Sponsor
Hamdard University
Who can join
Adults 30 to 70, any sex, with Diabetes Mellitus or Type 2 DM. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06841497
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06841497 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hamdard University
- Last refreshed: 24 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06841497.
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