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临床试验/CTRI/2024/09/074373
CTRI/2024/09/074373尚未招募2 期

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.

State Government1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年10月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
21
试验地点
1
主要终点
Improvement in ACQ score, Improvement in signs and symptoms of DIQ AL -

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Improvement in ACQ score, Improvement in signs and symptoms of DIQ AL -

时间窗: 28 DAYS

Nafas (Bronchial Asthma)

时间窗: 28 DAYS

次要结局

  • Improvement in Spirometer parameters Hematological and biochemical assessment(28 DAYS)

研究者

发起方
State Government
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR MUSSADIQ AHMED S

GOVERNMENT UNANI MEDICAL COLLEGE

研究点 (1)

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