Treatment of mouth ulcer with Unani medicine Habb-e –Qula

Phase 3

Not yet recruiting

• Conditions: Recurrent oral aphthae,

• Registration Number: CTRI/2021/05/033782
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with QulÄ (Aphthous Ulcer) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at Day 0, Day 3 , Day 7 and Day 10. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 10days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Pharmacopoeial Formulation ‘Habb-e- Qula’

| | | | | |

| --- | --- | --- | --- | --- |

|**S. No.**

**Ingredients**

**Botanical/Scientific Name**

**Part Used**

**Quantity**

|1.

Raihan

*Ocimum sanctum* Linn.

Leaf

50g

|2.

Sang-e-Jarahat

Hydrated Magnesium Silicate

\_\_\_\_\_

50g

|3.

Sandal Safaid

*Santalum album* Linn.

Bark

50g

|4.

Zar-e-Ward

*Rosa damascene* Linn.

Pollen Grains

50g

|5.

Heel Khurd

*Elettariacardamomum*Maton.

Seeds

50g

|6.

Araq-e-Gulab

*Rosa damascena*Linn.

Distillate of Petals

50g

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-05-24
• Study Start: 2021-05-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Subjects of either sex in the age group of 18-65 years 2.
• Subjects with presence of single /multiple ulcers on the non-keratinized mucosa (labial, soft palate, buccal mucosa) With and without any of the following symptoms o Pain or burning sensation o Excessive salivation 2.
• Subjects with minor Aphthous Ulcers less than 1 cm in diameter.

Exclusion Criteria

• Traumatic ulcers 2.
• Disorders requiring long term treatment 3.
• Known cases of underlying systemic diseases such as Crohn’s disease, ulcerative colitis, Celiac disease, lupus erythematosus, Behcet’s disease, Cyclic neutropenia, immunodeficiency disorders, lichen planus and malignancy 4.
• Known allergy to any component of the test drug.
• Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of QulÄ (Aphthous Ulcer)	The patients will be assessed clinically at Day 0, Day 3 , Day 7 and Day 10

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	Investigations will be done at baseline and end of treatment

Trial Locations

Locations (2)

Clinical Research Unit (CRU), Kurnool; 🇮🇳 Kurnool, ANDHRA PRADESH, India

Regional Research Institute of Unani Medicine, Aligarh; 🇮🇳 Aligarh, UTTAR PRADESH, India

Clinical Research Unit (CRU), Kurnool

🇮🇳Kurnool, ANDHRA PRADESH, India

Dr Jawadul Haq

Principal investigator

9502443555

cru.kurnool@gmail.com