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CTRI Number  CTRI/2020/02/023639 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Asthma (difficulty in breathing) by Unani medicine Laooq-e- Zeequn Nafas 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Laooq-e- Zeequn Nafas in Zeequn Nafas (Bronchial Asthma) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ZN/BA/LZN/CLNVAL/CCRUM/18-19  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  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  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  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  
Infrastructural support : 1. Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2. Regional Research Institute of Unani Medicine (RRIUM), Chennai 3. Regional Research Institute of Unani Medicine (RRIUM), Bhadrak 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  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   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anwar Ahmed  Central Research Institute of Unani Medicine (CRIUM))  Research OPD Room Asthma, A G Colony Road, Opposite E S I Hospital, Erragadda
Hyderabad
TELANGANA 		 9440417005

dranwar_ahmed@yahoo.com 
Dr Hafiz C Md Aslam  Regional Research Institute of Unani Medicine (RRIUM)  Research OPD Room Asthma 1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU 		 9444786772

drhcmdaslam@rediffmail.com 
Dr Syed Abdullah Hussaini  Regional Research Institute of Unani Medicine (RRIUM)  Research OPD Room Asthma, Chandbali By-Pass Road
Bhadrak
ORISSA 		 06784251289

rriumbdk_unani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine (CRIUM)), Hyderabad  Submittted/Under Review 
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak  Submittted/Under Review 
Regional Research Institute of Unani Medicine (RRIUM), Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J452||Mild intermittent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laooq-e-Zeequn Nafas   5gm twice daily to be taken with lukewarm water for four weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Males and females of 18-65 years.
2.Patients of Bronchial Asthma for at least 6 months presenting with at least one of the following symptoms:
a.Wheeze
b.Shortness of breath
c.Chest tightness and cough that vary over time and in intensity,
d.Expiratory airflow limitation as suggested by
a decreased FEV1
3.Objective evidence for reversible airway obstruction (≥12% and ≥200 mL change in FEV1 and/or a 25% and 60 L/min change in PEFR) either spontaneously or after treatment.
4.Patients with Asthma Control Questionnaire Score > 1.5.  
 
ExclusionCriteria 
Details  1.FEV1/FVC ratio < 50%
2.Pregnant and lactating mother
3.Patient with other Respiratory Tract Infections, tuberculosis and malignancy.
4.Patient of Presence of chronic cough with expectoration for 2-3 months in each of 2 successive years.
5.Patient with co-morbidities, Diabetes Mellitus, Hepatic and Renal Insufficiency.
6.Patients with Tobacco Smoking.
7.Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
 
 
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 Zeequn Nafas (Bronchial Asthma)  4 weeks 
 
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="300"
Sample Size from India="300" 
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)   28/02/2020 
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)?  

Brief Summary   This study is designed as a multicentric open trial in patients with Zeequn Nafas (Bronchial Asthma). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Laooq-e- Zeequn Nafas 5gm twice daily with lukewarm water for four weeks.  The patients will be assessed at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be four weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Laooq-e- Zeequn Nafas

S. No.

Ingredients

Botanical / Chemical Name

Quantity
  1.  

Tukhm-e-Katan

Linum usitatissimum (Seed)

60 gm.
  1.  

Maghz Badam Shireen Muqashshar

Prunus amygdalus (Dehusk Kernel)

60 gm.
  1.  

Maweez Munaqqa

Vitis vinifera

30 gm.
  1.  

Kateera

Cochlospermum religiosum (Gum)

30 gm.

  1.  

Asl-us-Soos

Glycyrrhiza glabra

30 gm.
  1.  

Maghz-e-Chilghoza

 Pinus gerardiana (Kernel)

30 gm.
  1.  

Nishasta-e-Gandum

Triticum aestivum 

30 gm.
  1.  

Samagh-e-Arabi

Acacia arabica (Gum)

30 gm.
  1.  

Tukhm-e-Hulba

Trigonella foenum-graecum (Seed)

10 gm
  1.  

Qand Safaid

Sugar

600 gm
 
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