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 Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Improvement in ACQ score, Improvement in signs and symptoms of DIQ AL -
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •Non smoker.
Exclusion Criteria
- •Patients below 18yrs.
- •and above 60 yrs.
- •Patient with Upper Respiratory Tract infection, chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
- •Patients with Comorbidities, Diabetes, Hepatic Disorders, Renal insufficiency, Hypertension and Heart diseases.
- •Patient with other respiratory tract infection, pulmonary Tuberculosis, occupational lung diseases and Malignancy.
- •Patient with Cognitive impairment.
- •Patient with regular use of oral or systemic corticosteroids for condition other than Asthma.
- •7.FEV1/FVC ratio ≤ 80
- •History of addiction (Smoking, alcohol, drugs)
- •Pregnant and lactating women.
Outcomes
Primary Outcomes
Improvement in ACQ score, Improvement in signs and symptoms of DIQ AL -
Time Frame: 28 DAYS
Nafas (Bronchial Asthma)
Time Frame: 28 DAYS
Secondary Outcomes
- Improvement in Spirometer parameters Hematological and biochemical assessment(28 DAYS)
Investigators
DR MUSSADIQ AHMED S
GOVERNMENT UNANI MEDICAL COLLEGE