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CTRI Number  CTRI/2013/12/004257 [Registered on: 30/12/2013] 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 formulations in Commom Cold  
Scientific Title of Study   Validation of Unani Pharmacopoeial formulation- Habb-e- Shifa for symptomatic relief in patients of Nazla-e- Hār (Common Cold)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ABDUL HANNAN 
Designation  Joint Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
Address  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
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
New Delhi
DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ABDUL HANNAN 
Designation  Joint Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
Address  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
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

DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum605@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR ABDUL HANNAN 
Designation  Joint Director (Unani) 
Affiliation  Central Council for Research in Unani Medicine (CCRUM),  
Address  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
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

DELHI
110058
India 
Phone  01128521981  
Fax  01128522965  
Email  ccrum605@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support : 1. Regional Research Institute of Unani Medicine(RRIUM), Bhadrak 2. RRIUM Chennai 3. RRIUM Mumbai 4. RRIUM Patna 5. Regional Research Centre (RRC), Silchar 6. Clinical Research Unit (CRU), Karimganj 7. Clinical Research Unit (CRU), Kurnool Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM New Delhi 
Address  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.  
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, Assam  Masjid Road, Karimganj, Assam
Karimganj
ASSAM 		 03843267522
03843267522
crukxj522@gmail.com 
Dr Jawadul Haq  Clinical Research Unit (CRU), Kurnool  DR ABDUL HAQ UNANI MEDICAL COLLEGE, 40/23 PARK ROAD, KURNOOL -518001
Kurnool
ANDHRA PRADESH 		 09502443555

cru.kurnool@gmail.com 
DR Mustehasan  Regional Research Centre (RRC), Silchar, Assam  S.M. Dev Civil Hospital, Silchar -1, Cachar, Assam
Cachar
ASSAM 		 03843267522
03843267522
mustehasan1971@gmail.com 
Dr Ziaul Haq Siddiqui  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, BHADRAK  Motel Chhak, Mathasahi, Bhadrak-756100 (Odisha)
Bhadrak
ORISSA 		 06784240289
06784240660
zhsccrum@gmail.com 
DR Hafiz C Mohd Aslam  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, CHENNAI   No.1, West Madha Church Road, Royapuram, Chennai-600 013
Chennai
TAMIL NADU 		 04425955519
04425955532
drhcmdaslam@rediffmail.com 
DR Masroor Qureshi  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, MUMBAI  Sir J.J. Hospital Compound, Byculla, Mumbai
Mumbai
MAHARASHTRA 		 02223718706
02223718706
drmseth@hotmail.com 
DR MANZAR AHSAN  REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, PATNA  IInd Floor, Shree Guru Gobind Singh Hospital, Patna – 800 008
Patna
BIHAR 		 06122631106
06122631106
manzarahsan9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Clinical Research Unit (CRU), Karimganj, Institutional Ethics Committee  Submittted/Under Review 
Clinical Research Unit Kurnool Institutional Ethics Committee  Approved 
REGIONAL RESEARCH CENTRE SILCHAR INSTITUTIONAL ETHICS COMMITTEE  Submittted/Under Review 
RRIUM BHADRAK INSTITUTIONAL ETHICS COMMITTEE  Approved 
RRIUM CHENNAI INSTITUTIONAL ETHICS COMMITTEE  Approved 
RRIUM MUMBAI INSTITUTIONAL ETHICS COMMITTEE  Submittted/Under Review 
RRIUM Patna INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], Nazla-e- Hār (Common Cold),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Habb-e- Shifa  1-2 Pills, orally two times daily after breakfast and dinner. one Pill for patients weighing up to 50 kg and two Pills pills for patients weighing more than 50 kg.  
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All subjects should meet the following criteria:
1- Patients of either sex in the age group of 18-65
2- Patients of Nazla-e- Hār (Common Cold) presenting with recent onset of any of the following symptoms:
• Khushūna al-Halaq (Sore throat)
• Buhha al-Sawt (Hoarseness of Voice)
• ‘Utās (Sneezing/ Nasal irritation)
• Sudā‘ (Headache)
• Su‘āl (Cough)
• Runny nose
• I‘yā (Malaise)
• Flushing of Face
• With or without low grade fever (<102 0F)

 
 
ExclusionCriteria 
Details  Patients will be excluded if they meet any of the following criteria:
1. Patients of acute or chronic lower respiratory tract infection like pneumonia, Bronchitis, Asthma and Bronchiectasis.
2. Fever 102oF
3. Known cases of any other acute illness
4. Pregnant and lactating women
5. Known case of Renal/ Hepatic/ Cardiac impairment or the ailment needs long term therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Nazla-e- Hār (Common Cold)

 		 1 week

 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment  1 WEEK 
 
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)   13/03/2013 
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="3"
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 Nazla-e- Hār (Common Cold). After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria.  The patients will be assessed clinically on follow up.  This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 1 week . Laboratory parameters for safety assessment will be conducted at baseline and end of study.

 

1-Tukhm Dhatura Siyah        (Datura stramonium Linn.)    3 Parts

2-Rewand Chini                     (Rheum officinale Baill.)      2 Parts

3-Zanjabil                                (Zingiber officinale Roscoe) 1 Part

4-Samagh Arabi                      (Acacia nillotica Willd.)        1 Part

 

 
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