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临床试验/NCT07787507
NCT07787507已完成不适用

Study on Anti-oxidative and Anti-Inflammatory Effects of Certain Herbs for Inflammatory Lung Diseases

Aligarh Muslim University0 个研究点目标入组 120 人开始时间: 2026年2月15日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
120
主要终点
Change in FEV1 Percent Predicted

研究概览

简要总结

This randomized, double-blind, placebo-controlled study evaluated Withania somnifera root powder as a complementary therapy in adults with moderate-to-severe persistent asthma receiving standard asthma treatment. Participants were assigned to standard treatment alone, standard treatment plus placebo, or standard treatment plus Withania somnifera root powder for 10 weeks. Lung function, asthma control, quality of life, systemic oxidative stress, and inflammatory and allergic biomarkers were assessed before and after the intervention to evaluate the potential additional benefits of Withania somnifera in asthma management.

详细描述

This randomized, double-blind, placebo-controlled clinical study was conducted at Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India. Adults aged 18-50 years with moderate-to-severe persistent asthma were included in the study. Eligible participants were non-smokers and were receiving standard asthma medication. Patients with recent respiratory tract infection, pregnancy or lactation, serious comorbid conditions, or hospitalization within the previous month were excluded.

Participants were allocated using computer-generated randomization to three groups: a control group receiving conventional asthma treatment, a placebo group receiving conventional treatment plus starch capsules, and a Withania somnifera-treated group receiving conventional treatment plus Withania somnifera root powder capsules. The Withania somnifera intervention consisted of 300 mg root powder administered orally twice daily for 10 weeks.

Clinical assessments were performed at baseline and after the 10-week intervention. Lung function was evaluated by spirometry using FEV1 percent predicted, FVC percent predicted, and the FEV1/FVC ratio. Asthma control was assessed using the Asthma Control Test, and quality of life was evaluated using the Asthma Quality of Life Questionnaire.

Blood samples were collected for assessment of systemic oxidative stress, inflammation, and allergic markers. Evaluations included total antioxidant capacity, malondialdehyde, total sulfhydryl groups, neutrophil and eosinophil percentages, and circulating IL-4, IL-8, IL-13, IL-17A, and IgE levels. Plasma samples were stored at -80°C until laboratory analysis.

The study was reviewed and approved by the Institutional Ethical Committee of Jawaharlal Nehru Medical College, Aligarh Muslim University (IECJNMC/628), and written informed consent was obtained from the participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 50 years Moderate to severe persistent asthma Non-smokers Receiving standard asthma medications for no more than one month

排除标准

  • Recent respiratory tract infection Pregnant or lactating women Serious comorbid conditions Hospitalization within the previous one month

结局指标

主要结局

Change in FEV1 Percent Predicted

时间窗: Baseline and after 10 weeks of intervention

Forced expiratory volume in one second (FEV1) percent predicted was measured by spirometry to assess lung function before and after the intervention.

次要结局

  • Change in Total Antioxidant Capacity(Baseline and after 10 weeks of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Priyam Singh

PhD Research Scholar

Aligarh Muslim University

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