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CTRI Number  CTRI/2024/02/063365 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of difficulty or trouble in breathing with Unani medicine Laooq Zeequnnafas Balghami 
Scientific Title of Study   Clinical validation of Unani pharmacopoeial formulation Laooq Zeequnnafas Balghami in Zeeq un Nafas (Bronchial asthma)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ZN/BA/LZNB/CLNVAL/CCRUM/2021-2022, version 01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Zaheer Ahmed  
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  drnzaheer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naheed Parveen  
Designation  Deputy Director General 
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  naheedparveen802@gmail.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  
Infrastructural support : 1 Regional Research Institute of Unani Medicine, Mumbai 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shah Alam  Regional Research Institute of Unani Medicine, Mumbai  Research OPD Room, Bronchial Asthma, Plot no. 38-39, Sector-18, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA 		 7008498476

shahccrum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Regional Research Institute of Unani Medicine, Mumbai  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 Zeequn Nafas Balghami   5g (semisolid) to be taken orally twice daily with lukewarm water for 4 weeks 
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 between the age group of 18-65 years.
2. Subjects of Bronchial Asthma for at least 6 months presenting with at least one of the following symptoms:
Wheeze
Shortness of breath
Chest tightness and cough that vary over time and
in intensity,
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. Subjects with Asthma Control Questionnaire Score > 1.5. 
 
ExclusionCriteria 
Details  1. FEV1/FVC ratio < 50%
2. Pregnant and lactating females
3. Subjects with other Respiratory Tract Infections, tuberculosis and malignancy.
4. Subjects with co-morbidities; Diabetes Mellitus, Hepatic and Renal Insufficiency
5. Subjects with known interstitial lung disease.
6. Subjects with Tobacco Smoking.
7. Subjects with known chronic obstructive pulmonary disease (COPD)
8. Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
9. Subjects who are not willing to participate in the study. 
 
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 Zeeq un Nafas (Bronchial asthma) on the basis of Asthma Control Questionnaire (ACQ), Pulmonary Function Test:FEV1, FEV1/FVC ratio, PEFR by Spirometry, Absolute Eosinophil Count(AEC)  At week 1, 2, 3 and 4 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment  At baseline and after 4 weeks 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   05/03/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
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 single centric open trial in patients with Zeeq un Nafas (Bronchial asthma). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every week for 4 weeks for improvement in patients with Bronchial Asthma. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Lauqe Zeequn Nafas Balghami

S. No.

Ingredients

Botanical / Chemical Name

Quantity
  1.  

Asl- us - soos

Glycyrrhiza glabra Linn.

15 g.
  1.  

Irsa (sausan)

Iris ensata Thunb.

15 g.
  1.  

Gule Gaozaban

Onosma bracteatum Wall.

15 g.

  1.  

Badiyan

Illicium verum. Hook

15 g.
  1.  

Zufa E Kushk

Hyssopus officinalis

15 g.
  1.  

Gul-e- Banafsha

 Viola odorata Linn.

15 g.

  1.  

Unnab

Ziziphus sativa Gaertn

25 g.
  1.  

Anjeer Zard

Ficus carica Linn.

25 g.
  1.  

Maveez Munaqqa

Vitis vinifera L.

30g.
  1.  

Tukhme Khatmi

Althea officinalis Linn

20 g.
  1.  

Khubbazi

Malva sylvestris

20 g.

  1.  

Parsiaoshan

Adiantum capillus-veneris

20 g.
  1.  

Nabat Safed

Sugar crystal

1 kg
  1.  

Asal

Shorea robusta

70 g.
  1.  

Samaghe Arabi

Acacia arabica (lam.)

5 g.
  1.  

Rubus Soos

Glycyrrhiza glabra Linn.

5 g.
  1.  

Maghz e Chilghoza

Pinus gerardiana

5 g.

  1.  

Mastagi

Pistacia lentiscus Linn

5 g.
  1.  

Darchini

Cinnamomum verum

5 g.
 
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