A Single-Center, Open-Label, Clinical Study to evaluate the safety and efficacy of Sairub Heal and Immunocare drops for the treatment of respiratory viral infections
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1.Change in Forced Expiratory Volume in 1 Second (FEV1).
研究概览
简要总结
Background
Respiratory viral infections (RVIs) are a major cause of acute illnesses worldwide, leading to substantial morbidity and healthcare burden. Common causative viruses include rhinovirus, influenza viruses, respiratory syncytial virus (RSV), adenoviruses, and coronaviruses, with symptoms ranging from mild upper respiratory tract infections to severe conditions like pneumonia or acute exacerbations of asthma and COPD. Despite available antiviral drugs and vaccines, their variable efficacy depends on the virus, strain mutation, host immunity, and timing of administration. Added to this, concerns about drug resistance issues, adverse effects, and cost have created growing interest in complementary and alternative approaches, including traditional systems of medicine like Ayurveda.
Sairub Heal is a proprietary Ayurvedic formulation in ointment form containing essential oils and extracts of herbs traditionally used for respiratory ailments. Immunocare Drops are administered sublingually and contain immune-supportive herbs designed to enhance host defense mechanisms. Sublingual absorption allows for rapid bioavailability without gastrointestinal degradation.
Purpose of the Study
The purpose of this phase 3 clinical study is to evaluate the safety and efficacy of Sairub heal and immunocare drops in the treatment of respiratory viral infections. The study also aims to assess improvement in forced expiratory volume in 1 second, peak expiratory flow rate, and oxygen saturation, and assess the effect of the PCR-confirmed intervention on the incidence of RVIs. It also aims to evaluate the changes in serum immunoglobulin G (IgG) levels to know the immunity, assess Subject satisfaction and perceived improvement using the Patient Global Impression of Change scale while evaluating the safety and tolerability of the intervention.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged 18 to 70 years. 2.Clinical diagnosis of respiratory viral infection including: a.Recent onset less than or equal to 2 days of bronchial mucus production with impaired cough. b.Presence of respiratory symptoms for example.
- •runny nose, cough, throat irritation or tickling. c.Presence of systemic symptoms for example.
- •weakness, myalgia, headache, chills, sweating. d.Symptoms such as fever, productive cough, dyspnea, or chest pain with oxygen saturation SpO2 greater than or equal to 94 percent on room air. e.Symptom frequency of more than once a week but less than once a day for example- wheeze, cough, breathlessness. 3.FEV1 greater than or equal to 60 percent predicted at screening. 4.Reversible airway obstruction confirmed by greater than or equal to 12 percent improvement in FEV1 post bronchodilator. 5.Ability and willingness to comply with study procedures and visit schedule. 6.Willingness to abstain from other respiratory treatments during the study, unless medically necessary. 7.Written informed consent obtained prior to any study related procedure.
排除标准
- •1.Requirement for antiviral medications during the study period.
- •2.Known primary or secondary immunodeficiency for example- HIV, immunosuppressive therapy.
- •3.History or suspicion of malignancy except benign neoplasms.
- •4.Active tuberculosis or other concurrent infections requiring antibiotic therapy.
- •5.Presence of aggravated or decompensated chronic disease that could interfere with study compliance.
- •6.Diagnosed malabsorption syndromes, including lactase or disaccharidase deficiency, galactosemia.
- •7.Known allergy or hypersensitivity to any components of Sairub Heal or Immunocare Drops.
- •9.Unwillingness or inability to use acceptable contraceptive methods during the study period.
结局指标
主要结局
1.Change in Forced Expiratory Volume in 1 Second (FEV1).
时间窗: Day 0, Day7 , Day 14
2.Change in Peak Expiratory Flow Rate (PEFR).
时间窗: Day 0, Day7 , Day 14
3.Change in Oxygen Saturation (SpO2).
时间窗: Day 0, Day7 , Day 14
4.PCR-confirmed incidence of respiratory viral infection.
时间窗: Day 0, Day7 , Day 14
次要结局
- 1.Change in Serum Immunoglobulin G (IgG) levels.(2.Patient Global Impression of Change (PGIC).)
研究者
Dr Manjunath U
Currex Hospital