| CTRI Number |
CTRI/2025/08/093638 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of mouth sore (Stomatitis) with unani medicine Qulai and Zaroor Kath |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Q/S/Q/ZK/CLNVAL/CCRUM/23-24, Version NO- 01, 06.07.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
DELHI
110058
India |
| Phone |
09811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: National Research Institute of Unani Medicine and Skin Disorders (NRIUMSD), (Erstwhile Central Research Institute of Unani Medicine) Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad – 500838 |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Masood Ahmad |
National Research Institute of Unani Medicine for Skin Disorders |
Research OPD Room Qulaa (stomatitis), Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad – 500838
Hyderabad
TELANGANA |
7983383071
masood71.ccrum@ccrum.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K12||Stomatitis and related lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qulai |
Liquid applied on the mucosa of the oral cavity Twice daily for 14 days. |
| Comparator Agent |
Zaroor Kath
|
Powder applied on the mucosa of
the oral cavity Twice daily for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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) |
At 0, 7th and 14th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT,KFT. |
At baseline and at the end of treatment. i.e., 0 & 14th day.
|
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a Single centric, Randomized, Parallel Group, Active Controlled trial in patients with Qulaa (Stomatitis). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at 0, 7th and 14th day. The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Pharmacopoeial Formulation ‘Qulai’ | S. No. | Ingredients | | Quantity | | 1. | Hamiz Booraqi | Boric Acid | 30 g. | | 2. | Shahdeen | Glycerin | 150 g. |
Composition of Pharmacopoeial Formulation ‘Zaroor Kath’ | S. No. | Tibbi Name | Scientific Name | Parts used | Quantity | | 1 | Zar-e- Ward | Rosa damascena Mill. | Pollen grains | 1 part | | 2 | Kat Safed | Acacia catechu (Linn. f.) Willd. | Extract | -do- | | 3 | Dana Heel Khurd | Elettaria cardamomum (Linn.) Maton | Seeds | -do- | | 4 | Tabasheer | Bambusa arundinacea (Retz.) Roxb. | Siliceous secretion | -do- | | 5 | Kafoor | Cinnamomum camphora (Linn.) J. Presl | Extract | -do- |
|