| CTRI Number |
CTRI/2021/05/033782 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
24/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of mouth ulcer with Unani medicine Habb-e –Qula |
|
Scientific Title of Study
|
Clinical study on Validation of Unani Pharmacopoeial formulation Habb e Qula in QulÄ (Aphthous Ulcer) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Q/AU/HQ/CLNVAL/CCRUM/19-20, version 2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| 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
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room no. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.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
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh 2. Clinical Research Unit (CRU), Kurnool |
|
|
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jawadul Haq |
Clinical Research Unit (CRU), Kurnool |
Research OPD Room QulÄ (Aphthous Ulcer) Dr Abdul Haq Unani Medical College, 40/23 PARK ROAD
Kurnool
ANDHRA PRADESH |
9502443555
cru.kurnool@gmail.com |
| Dr Shagufta Rehman |
Regional Research Institute of Unani Medicine, Aligarh |
Research OPD Room QulÄ (Aphthous Ulcer) Post Box No. 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road
Aligarh
UTTAR PRADESH |
9456667107
drrehmanshagufta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit (CRU), Kurnool |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K120||Recurrent oral aphthae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Qula |
1 Habb/tablet (250 mg) orally twice daily to be chewed for 2-5 min then swallowed. duration of treatment is 10days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 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 |
|
| ExclusionCriteria |
| Details |
1. 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. Subjects with moderate to severe anemia
5. Known allergy to any component of the test drug.
6. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 3 |
|
Date of First Enrollment (India)
|
31/05/2021 |
| 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
|
Not yet |
|
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 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 | ElettariacardamomumMaton. | Seeds | 50g | | 6. | Araq-e-Gulab | Rosa damascenaLinn. | Distillate of Petals | 50g | |