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Testing the Effectiveness of Traditional Unani Herbal Medicines in Treating Oral Submucous Fibrosis

TO EVALUATE THE EFFICACY OF POLYHERBAL UNANI FORMULATIONS IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS OPEN LABEL INTERVENTIONAL CLINICAL TRIAL MANAGEMENT OF ORAL SUB-MUCOUS FIBROSIS OPEN LABEL INTERVENTIONAL CLINICAL TRIAL - OSMF

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093407
Enrollment
43
Registered
2025-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Khamira Banafsha and Barg i Rehan sabz: 20 grams Khamira Banafsha twice daily after meal with normal water for 12 weeks. 5 to 6 gm fresh leaves of Rehan by chewing per day for 12 weeks.

Sponsors

State Unani Medical College and HAHRDM hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients having clinical signs and symptoms of OSMF with a documented history of consuming chewing tobacco areca nut pan masala or gutka as the primary etiological factor scoring 6 or below based on the classification given by SK Katharia37 The patients willing to give written informed consent to do protocol follow up

Exclusion criteria

Exclusion criteria: Extensive fibrosis and or with severe trismus with an Inter Incisal Distance less than or equal to 17mm Disease is most advanced with known malignant changes Patients on any treatment for OSMF In case they are then such a treatment would be stopped and a washout period of 2 weeks would be given Pale oral mucosa of anemia mimicking blanching Pregnancy 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 not willing to give up addiction habits of Gutka Pan Masala tobacco

Design outcomes

Primary

MeasureTime frame
LIKERT scale VAS scaleTimepoint: 0 3 6 9 and 12 weeks

Secondary

MeasureTime frame
IID Inter Incisal DistanceTimepoint: 0 3 6 9 and 12 weeks

Countries

India

Contacts

Public ContactAlisha Adil

State Unani Medical college and HAHRDM hospital

dr.yalamlam@gmail.com6395496007

Outcome results

None listed

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