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CTRI Number  CTRI/2024/09/074373 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 09/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Traditional Unani Medicine Decoction May Help in Managing Bronchial Asthma 
Scientific Title of Study   EFFECTS OF POLYHERBAL UNANI FORMULATION JOSHANDA (DECOCTION), IN THE TREATMENT OF DIQ AL-NAFAS (BRONCHIAL ASTHMA), NON RANDOMIZED, A SINGLE –ARM, PRE AND POST INTERVENTIONAL STUDY WITHOUT CONTROL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MUSSADIQ AHMED S 
Designation  PG SCHOLAR 
Affiliation  GOVERNMENT UNANI MEDICAL COLLEGE 
Address  GOVERNMENT UNANI MEDICAL COLLEGE ARINGAR ANNA HOSPITAL CAMPUS ARUMBAKKAM CHENNAI

Chennai
TAMIL NADU
600106
India 
Phone  9566471448  
Fax    
Email  mussy.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR A KHALEEL AHMED MD  
Designation  Assistant Professor 
Affiliation  GOVERNMENT UNANI MEDICAL COLLEGE  
Address  PG Department of Moalajat. GOVERNMENT UNANI MEDICAL COLLEGE ARINGAR ANNA HOSIPTAL CAMPUS ARUMBAKKAM CHENNAI.

Chennai
TAMIL NADU
600106
India 
Phone  7358321528  
Fax    
Email  ahmedkhaleel869@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR A KHALEEL AHMED MD  
Designation  Assistant Professor 
Affiliation  GOVERNMENT UNANI MEDICAL COLLEGE  
Address  PG Department Of Moalajat GOVERNMENT UNANI MEDICAL COLLEGE ARINGAR ANNA HOSIPTAL CAMPUS ARUMBAKKAM CHENNAI

Chennai
TAMIL NADU
600106
India 
Phone  7358321528  
Fax    
Email  ahmedkhaleel869@gmail.com  
 
Source of Monetary or Material Support  
STATE GOVERNMENT, Govt of TamilNadu . GOVT UNANI MEDICAL COLLEGE. Arumbakkam.Chennai.600106 
 
Primary Sponsor  
Name  State Government 
Address  GOVT UNANI MEDICAL COLLEGE ARUMBAKKAM CHENNAI-600106 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 MUSSADIQ AHMED S  PG Department of Moalajat OP.NO: 5M ARINGAR ANNA GOVT HOSPITAL OF INDIAN MEDICINE.  Government Unani Medical College,ARUMBAKKAM.CHENNAI.106
Chennai
TAMIL NADU 
9566471448

mussy.dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  POLYHERBAL UNANI FORMULATION JOSHANDA ,DECOCTION OF 1.Baranjasif [Achillea mellifolium Linn] 2. Hasha [Thymus serpyllum Linn] 3.Zarawand Madahraj [Aristocolia rotunda Linn] 4.Zufa[Hyssopus officinalis Linn]   UNANI POLYHERBAL FORMULATION, JOSHANDA. DOSAGE : 20gms.BID DURATION : 28days (7, 14, 21, 28)  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either gender in age group of 18-60yrs
2.Patients of Bronchial Asthma for at least 6 months presenting with at least are the following Symtoms
wheeze
Shortness Of Breath
Chest tightness & cough that vary overtime intensity
Expiratory airflow limitation as suggested by a decreased FEV1≥80
3.Patient with Asthma Control Test ≥ 19
4. Non smoker 
 
ExclusionCriteria 
Details  1. Patients below 18yrs. and above 60 yrs.
2. Patient with Upper Respiratory Tract infection, chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
3. Patients with Comorbidities, Diabetes, Hepatic Disorders, Renal insufficiency, Hypertension and Heart diseases.
4. Patient with other respiratory tract infection, pulmonary Tuberculosis, occupational lung diseases and Malignancy.
5. Patient with Cognitive impairment.
6. Patient with regular use of oral or systemic corticosteroids for condition other than Asthma.
7.FEV1/FVC ratio ≤ 80
8. History of addiction (Smoking, alcohol, drugs)
9. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in ACQ score, Improvement in signs and symptoms of DIQ AL -
Nafas (Bronchial Asthma)  
28 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in Spirometer parameters Hematological and biochemical assessment   28 DAYS 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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)   08/10/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Asthma is a chronic inflammatory paroxysmal disease characterized by spastic contraction of smooth muscle in bronchioles, which can cause extreme difficulty in breathing. Hallmark of the disease are increased airway responsiveness, bronco-constriction, inflammation of bronchial walls and increased mucus secretion.

Bronchial asthma clinically present as paroxysmal dyspnoea, cough, chest tightness and breathlessness, especially at night. Asthma has been declared as a disease of major public health importance by World Health Organization (WHO).An optimal strategy for asthma management and prevention was implemented in 1992 by Global initiative for Asthma (GINA) which was contributed by WHO and the National Heart, Lungs and Blood Institute (NHLBI) 1, 2.                                                     

 The 2020 Global Strategy for Asthma management and Prevention by the Global Initiative for Asthma (GINA) defined asthma as a heterogeneous disease characterized by chronic airway inflammation and variable remodelling that results in a range of clinical presentation, treatment responses and natural history across the life course of the patient (GINA, 2020) Asthma is one of the chronic disease of airway globally 3, 4                                                                            

             Asthma remains one of the most Important non-communicable diseases             (NCDs)  

The line of management of bronchial asthma is conventional medicine is mainly with bronchodilator therapies, anti-cholinergic, corticosteroids etc.5 Though these drug give swift relief of symptoms but they have systemic side effects including immunosuppression, obesity, osteoporosis, gastric ulceration etc. 6.  Chronicity of the disease also limits, the use of drug over a long period of time 7 considering the unconvincing scenario regarding the use of drug and side effects.

Therefore researchers are pursuing golden formula of timing of nature and the traditional pathies .Hence to provide an everlasting effect with less or no side effects Unani medicine axiomatically comes to the fore as [DIQ AL-NAFAS] Bronchial asthma has successfully been treated since ancient time without considerable obnoxious side effect on the body 8, 9

The line of treatment has been mentioned in a classical literature as following;

Ta’deel-e-Mizaj (correction of temperament), Tanqiyq Mawad (cleansing of viscous humour) mulattif (resolving), Munaffis-e-Balgham, and Mukhrij-e-Balgham (expectorants) drugs are recommended. Sometimes Muqi (emetics) Muhallil-e-Auram (anti- inflammatory) and Daf-e-Tashunnuj (anti- spasmodic) also recommend for evacuation of balgham, 10-15. So keeping in view the following unani polyherbal formulation 16 decoction [ joshanda ]17  has been selected from Kitaul Almuqtarath fit tib . To see the effectiveness in DIQ AL-NAFAS

*    Baranjasif              [Achillea mellifolium Linn]

*    Hasha                     [Thymus serpyllum  Linn]

*    Zarawand             [ Aristocolia rotunda Linn]  

Madahraj

          Zufa                             [Hyssopus officinalis Linn]

I          INTERVENTION

            DRUG                                          : UNANI POLYHERBAL FORMULATION,                                                                     JOSHANDA.

 

           DOSAGE                          : 20gms.BID

DURATION                     : 28days (7, 14, 21, 28)

           INDICATION                        : Wheezing, cough, breathlessness                                                          

            REFERENCE                     : Hassan AAB. Kitabul Almuqtarath fit                                                                                   tib.                                  

                                                               CCRUM. New delhi.PP:196

 
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