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Treatment of mouth sore (Stomatitis) with unani medicine Qulai and Zaroor Kath

A Randomized, Open-Label, Parallel Group, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a Unani Pharmacopoeial formulation Qulai compared with Dharur Kath in the Treatment of Qula (Stomatitis) - NILL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093638
Enrollment
110
Registered
2025-08-25
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: K12- Stomatitis and related lesions

Interventions

Intervention1: Qulai: Liquid applied on the mucosa of the oral cavity Twice daily for 14 days. Control Intervention1: Zaroor Kath : Powder applied on the mucosa of the oral cavity Twice daily for 14

Sponsors

Central Council for Research in Unani Medicine CCRUM New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects with presence of single/multiple ulcers on the non- keratinized mucosa (labial, soft palate, buccal mucosa) with/ without any of the following symptoms: 1. Difficulty in eating/chewing/swallowing/speaking. 2. Pain or burning sensation. 3. Excessive salivation.

Exclusion criteria

Exclusion criteria: 1. Subjects with Aphthous Ulcers more than 1cm in diameter. 2.Patients with Traumatic ulcers. 3. Patients with disorders requiring long term treatment. 4. Known cases of underlying Gastro-intestinal diseases such as Crohn?s disease, ulcerative colitis etc. 5.Subjects with severe anemia i.e. Hb level less than 8 gm % 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
The safety and efficacy of Unani Pharmacopeial formulation Qulai in comparison with Zaroor Kath in Qulaa (Stomatitis) will be carried out on the basis of Visual Analog Scale (VAS)Timepoint: At 0, 7th and 14th day

Secondary

MeasureTime frame
Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT,KFT.Timepoint: At baseline and at the end of treatment. i.e., 0 & 14th day.

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

javed.ghazal@gmail.com09811810454

Outcome results

None listed

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