A single centre, prospective, randomized, open labelled clinical study to evaluate the effectiveness of Siddha herbal formulation, Vipro, in uncomplicated respiratory infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Reducing the severity of clinical symptoms such as fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache
研究概览
简要总结
This study is a single centre, prospective, randomized, open labeled clinical study to evaluate the effectiveness of Siddha herbal formulation, Vipro, towards the management of uncomplicated respiratory infection including common cold with / without fever, flu like respiratory infection, bacterial respiratory infection and unidentified SARS-CoV-2-like respiratory infection.
The patients will be enrolled at Chettinad Hospital and Research Institute, Kelambakkam, with prior informed consent.
The subjects will be grouped into three as follows.
Group 1: Standard treatment (symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician)
Group 2: Liquid, oral, poly herbal formulation ‘Vipro’, one teaspoon of formulation, mixed in a glass of water, mixed thoroughly and swallowed after food for 7 days, for four times a day, morning, afternoon, evening and night.
Group 3: Standard Treatment + Vipro combination will be advised as in group 1 and 2
Baseline assessment on day 0:
The patients who fulfill the inclusion and exclusion criteria will be enrolled in the study. They will be allocated to any of the treatment groups as per the randomization. The following baseline data will be collected.
- Demographic profile - age, gender, height, weight and BMI will be recorded
- Blood pressure, Pulse, SpO2, Respiratory rate, Body temperature and constitutional symptoms
- General examination, systemic clinical examination
- Complete blood count (with 5 ml of blood drawn) and Throat / Nasal swab for bacterial culture and sensitivity
- Chest X ray and Nasal / Throat swab for COVID - when indicated as per the opinion of the treating physician
After the baseline assessment, the subjects will be provided with any one of the following treatments.
Group 1: Symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician
Group 2: Liquid, oral, poly herbal formulation ‘Vipro’, one teaspoon of formulation, mixed in a glass of water, mixed thoroughly and swallowed after food for 7 days, for four times a day, morning, afternoon, evening and night.
Group 3: Combination of both treatments of group 1 and 2
Follow up assessment (days 1 to 7):
Telephonic follow up (days 1 to 7) – Reminder for medication intake (daily once), Adverse events (daily once), Clinical symptoms for improvement / worsening (daily once), body temperature and constitutional symptoms
Physical follow up (On days 4 and 7) – Checking medication compliance, Blood pressure, Pulse, SpO2, Respiratory rate, Body temperature, constitutional symptoms, adverse events, General and Systemic examination, clinical signs and symptoms
During follow up - Complete blood count (with 5 ml of blood drawn) and Throat / Nasal swab for culture and sensitivity on day 7. Chest X ray and Throat / Nasal swab for COVID - when indicated as per the opinion of the treating physician.
If the subjects are found to deteriorate with the treatments followed, they will be withdrawn from the study and suitable alternate treatment will be provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Having uncomplicated respiratory infections, at least for less than 5 days, diagnosed with clinical symptoms and signs of fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache
- •Consenting to participate in the study and sign the informed consent.
排除标准
- •Patients with uncontrolled co-morbid conditions like Diabetes mellitus, Hypertension and Bronchial asthma
- •Patients with Lower respiratory tract infections, Chronic Bronchitis, Chronic obstructive air way problems
- •Patients with significant Cardiovascular, Neurological , Psychiatric, Gastro intestinal and other system infections or disorders and malignancies
- •Hypersensitivity to the herbal ingredients in the formulations and other medications prescribed in the study
- •Pregnant and feeding mothers
- •When the patients are interviewed for selection, all those patients who come under the testing criteria for COVID-19 as per ICMR guidelines will be tested for COVID – 19 and if they are found to be positive, they will be excluded from participating in the study.
结局指标
主要结局
1. Reducing the severity of clinical symptoms such as fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache
时间窗: Daily for 7 days
次要结局
- 1. Reducing the worsening of clinical symptoms(2. Reducing the complications)