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A study to assess the efficacy of Rasaut hamrah Lemu in patients of Oral submucous fibrosis.

An open label interventional clinical trial to evaluate the efficacy of a Unani formulation in the treatment of oral submucous fibrosis. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099844
Enrollment
50
Registered
2025-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Rasaut Hamrah Lemu: 2-3gm, Grind and rub inside the mouth twice daily for 12 weeks Control Intervention1: NIL: NIL

Sponsors

Salman Ahmad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting with clinical signs and symptoms of OSMF, with history of chewing or consuming tobacco, areca nut, pan masala, or gutka as the primary etiological factor, and having a score of 6 or below according to the classification given by SK Katharia. Patients who are willing to provide written informed consent and comply with the study protocol follow-up. Patient of either gender and disease severty- mild to moderate oral submucosal fibrosis.

Exclusion criteria

Exclusion criteria: Pregnancy or lactation, chronic debilitating conditions such as DM, HTN, HIV, Hepatitis B, bleeding disorders, cardiovascular diseases, renal dysfunction, liver disorders, mucosal disease or any other skin lesions and a known allergy or contraindication to the study drug. Patients on any treatment for OSMF. In case they are, then such a treatment would be Washout period of 2 weeks would be given. Pale oral mucosa of anemia mimicking blanching.

Design outcomes

Primary

MeasureTime frame
Subjective parameters-difficulty in eating, chewing, uneasiness in swallowing, speaking will be recorded on LIKERT Scale, and burning sensation in mouth will be recorded on VAS Scale. Objective parameter- By Inter incisal distance (IID) to measure the change in mouth opening.Timepoint: At basline, third, sixth, ninth, and twelfth week

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactSalman Ahmad

State Unani Medical College and Hospital

dr.yalamlam@gmail.com6395496007

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026