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CTRI Number  CTRI/2015/03/005633 [Registered on: 13/03/2015] Trial Registered Retrospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Safety and efficacy of Unani medicine in the treatment of inflammation of the mouth and lips (stomatitis) 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial formulation- Zaroor Kath for symptomatic relief in patients of Qulā‘ ( Stomatitis) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Q/S/ZK/CCRUM VERSION 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF S SHAKIR JAMIL 
Designation  DIRECTOR GENERAL  
Affiliation  Central Council for Research in Unani Medicine (CCRUM)  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  unanimedicine@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR K M SIDDIQUI 
Designation  DEPUTY DIRECTOR GENERAL 
Affiliation  Central Council for Research in Unani Medicine (CCRUM)  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  9810161758  
Fax  01128522965  
Email  ccrum507@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar  
Designation  RESEARCH OFFICER SCIENTIST III  
Affiliation  Central Council for Research in Unani Medicine (CCRUM)  
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  drpradeepkumar2001@yahoo.com  
 
Source of Monetary or Material Support  
Infrastructural support 1 Regional Research Institute of Unani Medicine,Bhadrak 2.Regional Research Institute of Unani Medicine,Chennai 3.Regional Research Institute of Unani Medicine,Patna 4.Regional Research Institute of Unani Medicine,Mumbai 5.Regional Research Centre, Silchar 6.Clinical Research Unit,Karimganj 7.Clinical Research Unit,Kurnool Monetary Support : CCRUM,NEW DELHI  
 
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  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR WAHIDUZZAMAN  Clinical Research Unit (CRU), Karimganj   Masjid Road, Karimganj
Karimganj
ASSAM 		 03843267522

crukxj522@gmail.com 
Dr Jawadul Haq   Clinical Research Unit (CRU), Kurnool   DR ABDUL HAQ UNANI MEDICAL COLLEGE, 40/23 PARK ROAD
Kurnool
ANDHRA PRADESH 		 09502443555

cru.kurnool@gmail.com 
DR RASHIDUL ISLAM ANSARI  Regional Research Centre (RRC), Silchar  S.M. Dev Civil Hospital, Silchar -1
Cachar
ASSAM 		 08486336761

waytorashid@gmail.com 
DR AKTHER HUSSAIN JAMALI  Regional Research Institute of Unani Medicine (RRIUM), Bhadrak   Chandbali Byepass road
Bhadrak
ORISSA 		 06784251289

rriumbdk_unani@yahoo.co.in 
Hkm Aijaz Ahmed  Regional Research Institute of Unani Medicine (RRIUM), Chennai  No.1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU 		 04425955532

rriumchennai@gmail.com 
DR MOHAMMAD RAZA  Regional Research Institute of Unani Medicine (RRIUM), Mumbai   Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA 		 0222371806

rrium.mumbai@gmail.com 
DR S MANZAR AHSAN  Regional Research Institute of Unani Medicine (RRIUM), Patna  Manas Path opp. Patna City Hospital
Patna
BIHAR 		 06122631106

rriumpatna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinical Research Unit (CRU), Karimganj  Submittted/Under Review 
Clinical Research Unit (CRU), Kurnool  Approved 
Regional Research Centre (RRC), Silchar  Submittted/Under Review 
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Chennai  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Mumbai  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K121||Other forms of stomatitis, Qulā (Stomatitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  na 
Intervention  Zaroor Kath  Local Q.S. twice daily, Powder to be sprinkled on the lesions for a period of seven days  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Patients of either sex in the age group of 10-65
• Presence of single /multiple ulcers in the oral cavity and tongue
With and without
Presence of any of the following symptoms
o Difficulty in eating/ chewing/Uneasiness in Speaking /Swallowing
o Burning sensation / Pain in the mouth
o Excessive salivation
o Coated tongue
 
 
ExclusionCriteria 
Details  • Disorders requiring long term treatment
• Known cases of underlying systemic diseases such as crohn’s disease, ulcerative colitis, Celiac disease, lupus erythematosus, behcet’s disease, Cyclic neutropenia, immunodeficiency disorders
• Known cases of carcinoma
• Patients with hemoglobin level < 8 g /dl
• Pregnant and lactating women.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Qulā‘ ( Stomatitis)  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment  7 weeks 
 
Target Sample Size   Total Sample Size="540"
Sample Size from India="540" 
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)   01/04/2014 
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)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is designed as a multicentric open trial in patients with Qulā‘ ( Stomatitis). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on 3rd and 7th day of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.

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-
 
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