Clinical comparative efficacy and safety of Polyherbal Unani formulations.

A Clinical Study to Evaluate the Efficacy and Safety of Polyherbal Unani Formulations in the Management of Qul ? (Aphthous stomatitis)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049696

Enrollment

Registered

2023-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: K120- Recurrent oral aphthae

Interventions

Intervention1: (Group A) Unani drugs habb-e-kabid naushadari(oral), polyherbal unani formulation(local) : Habb-e-kabid naushadari 500mg twice a day For 14 days. Local application of polyherbal Unani

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of any sex in the age group of 18-65 years 2.Presence of single/multiple ulcers in the oral cavity or tongue with the presence of any of the following symptoms Difficulty in any eating/chewing/speaking/swallowing or burning sensation, pain in the oral cavity,coated tongue, excessive salivation 3.Patients clinically diagnosed with Qul ? (Aphthous stomatitis)

Exclusion criteria

Exclusion criteria: The following patients will be excluded 1.Pregnant and lactating mothers. 2.Patient with severe renal, hepatic, and cardiac disease. 3.Those who have a history of systematic underlying disease (Crohn’s disease, Ulcerative Colitis, Behcet’s syndrome, Sweet’s Syndrome, Lupus erythematosus) and Diabetes mellitus. 4.Those diagnosed with oral cavity carcinoma. 5. Patient of hypertension. 6.Patient unsure about attending treatment schedule regularly.

Design outcomes

Primary

Measure	Time frame
1. LIKERT Scale:-Difficulty in eating, chewing, uneasiness in swallowing and speaking will be assessed on a LIKERT Scale: Grade 0 – None of the time Grade 1 – some of the time Grade 2 – Most of the time Grade 3 – all of the time 2. ten-point Visual Analog Scale (VAS):-the following symptoms will be assessed on a ten-point Visual Analog Scale (VAS) • Burning sensation in the mouth • Excessive salivation • Coated tongueTimepoint: Baseline , 1 and 2 weeks	—

Measure

Time frame

1. LIKERT Scale:-Difficulty in eating, chewing, uneasiness in swallowing and speaking will be assessed on a LIKERT Scale: Grade 0 – None of the time Grade 1 – some of the time Grade 2 – Most of the time Grade 3 – all of the time 2. ten-point Visual Analog Scale (VAS):-the following symptoms will be assessed on a ten-point Visual Analog Scale (VAS) • Burning sensation in the mouth • Excessive salivation • Coated tongueTimepoint: Baseline , 1 and 2 weeks

—

Secondary

Measure	Time frame
• No. of ulcers in the oral cavity Grade 0 - No ulcer Grade 1 - 1-3 Grade 2 – 4-6 Grade 3 - =7 Timepoint: 0 and 13th day	—

Countries

India

Contacts

Public ContactDr Usamah Ahmad

State Unani Medical College

asifhussainusmani@gmail.com7905831926

Outcome results

None listed

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