| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
|
|
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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 |