COMPARING EFFECTIVENESS OF CAPSULE SILYMARIN WITH THAT OF SM FIBRO CAPSULE IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS

COMPARING CLINICAL EFFICACY OF SILYMARIN WITH THAT OF A STANDARD THERAPEUTIC COMBINATION OF LYCOPENE, ALPHA LIPOIC ACID AND TOCOPHEROL IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS-A RANDOMIZED CLINICAL TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061326

Enrollment

Registered

2024-01-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: - Health Condition 2: - Health Condition 3: K135- Oral submucous fibrosis

Interventions

Intervention1: CAPSULE SILYMARIN: DOSE - 400MG FREQUENCY - ONCE DAILY DURING NIGHT TIME ROUTE OF ADMINISTRATION - ORAL DURATION OF THERAPY - 8 WEEKS Control Intervention1: SM FIBRO CAPSULE COMPO

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed OSMF ( stage 1,2 & 3 as per the criteria put forward by the Tinky Bose and Anitha Balan. Patients who are ready to quit the habit

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
INCREASE IN MOUTH OPENINGTimepoint: AT A BASELINE OF 8 WEEKS	—

Secondary

Measure	Time frame
DECREASE IN FURTHER PROGRESSION OF CONDITIONTimepoint: 8 WEEKS	—

Countries

India

Contacts

Public ContactDr KAKARLA VENKATA SUSMITHA

DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, ROOM NUMBER 1, NARAYANA DENTAL COLLEGE AND HOSPITAL

dentkan1@gmail.com9490471078

Outcome results

None listed

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