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CTRI Number  CTRI/2015/02/005573 [Registered on: 24/02/2015] Trial Registered Prospectively
Last Modified On: 04/12/2018
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 Raughan Ikseer for symptomatic relief in Waja‘ al-Asnān (Toothache) 
Scientific Title of Study   Clinical Validation of a Unani Pharmacopoeial Formulation – Raughan Ikseer for symptomatic relief in Waja‘ al-Asnān (Toothache) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
WA /TA/RI CLNVAL / CCRUM 14-15  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF RAIS UR RAHMAN  
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  drrahman002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KHALID 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@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support 1. Regional Research Institute of Unani Medicine Bhadrak 2.Regional Research Institute of Unani Medicine Mumbai 3..Regional Research Institute of Unani Medicine Chennai 4.Regional Research Institute of Unani Medicine Patna 5.Regional Research Centre, Silchar 6.Clinical Research Unit, Kurnool Monetary Support : Central Council for Research in Unani Medicine, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine  
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 = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Hakim 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 Mustehasan   Regional Research Centre, Silchar  S.M. Dev Civil Hospital, Silchar -1, Cachar, Assam
Cachar
ASSAM 		 03843267522

mustehasan1971@gmail.com 
DR SHOAIB AHMAD KHAN  Regional Research Institute of Unani Medicine Bhadrak  Near Rural Police Station, Chandbali By Pass Road
Bhadrak
ORISSA 		 07205584347

rriumbdk_unani@yahoo.co.in 
DR K KABIRUDDIN  Regional Research Institute of Unani Medicine, Chennai  No 1 West Madha Road, Royapurum
Chennai
TAMIL NADU 		 0944219145

drk.kabiruddin@rediff.com 
Dr Masroor Ali Qureshi  Regional Research Institute of Unani Medicine, Mumbai  Sir J J Hospital, Byculla Compound
Mumbai
MAHARASHTRA 		 09004040670

drmasrooralig786@gmail.com 
DR MOHD ISHTIYAQ ALAM  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, PATNA   GUZRI, PATNA CITY
Patna
BIHAR 		 09431492087

mailme_dralam@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Clinical Research Unit (CRU), Kurnool  Submittted/Under Review 
Regional Research Centre, Silchar  Submittted/Under Review 
Regional Research Institute of Unani Medicine Bhadrak  Approved 
Regional Research Institute of Unani Medicine, Chennai  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Mumbai  Approved 
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, PATNA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K050||Acute gingivitis, Toothache,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  NA 
Intervention  Raughan Ikseer  Local application, twice daily for a period of seven days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Patients of either sex in the age group 18-65 years.
• Patients having Waja‘ al-Asnān (Toothache) with or without any of the following symptoms:
 Waram al-Lisa (Gingival swelling)
 Humra al-Lisa (Gingival erythema)
 Nazf al-Lisa (Gingival bleeding)
 Hassāsiyat Harāriyya (Thermal sensitivity) – Pain triggered by Cold or Heat
 Sudā‘ (Headache)
 
 
ExclusionCriteria 
Details  • Toothache does not respond to standard therapy.
• Toothache accompanied by impaired neurological functions (loss of balance, weakness, numbness, or speech disturbances), double vision, seizures, mental disturbances, and loss of consciousness.
• Toothache accompanied by persistent nausea, vomiting, fever and stiff neck.
• Presence of a periodontal abscess as diagnosed from clinical examination of the painful tooth.
• Presence of concomitant oral pain due to any other condition such as soft-tissue lesions (e.g., aphthous/ traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis) or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.
• Known cases of any other acute illness.
• Known cases of severe Renal/ Hepatic/ Cardiac ailments.
• Pregnant and lactating women.
• History of Hypersensitivity to the study drug or any of its ingredients.
• History of addiction (alcohol, drugs)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Waja‘ al-Asnān (Toothache)  7 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessments for safety
ï‚· Improvement in the feeling of well-being of the patient  		 7 DAYS 
 
Target Sample Size   Total Sample Size="384"
Sample Size from India="384" 
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)   01/03/2015 
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   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 Waja‘ al-Asnān (Toothache). Patients will receive the study drug  Raughan Ikseer, as local apploication twice daily for a period of 7 days. All the laboratory parameters will be recorded at baseline and at the end of the study. 

Composition of Raughan Ikseer

S. No.

Unani Name

Botanical Name

Weight

1.

Kafoor Khalis

Cinnamomum camphora

25 g

2.

Sat-e- Pudina

Mentha arvensis

10 g

3.

Sat-e- Ajwayin

Trachyspermum ammi

10 g
 
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