Efficacy and safety of Ap-Bio/Kalmcold in participants with uncomplicated upper respiratory tract viral infection (common cold) - A Phase III, double-blind, parallel group, randomized placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Severity symptom score assessed by WURSS-21
研究概览
简要总结
Kalmegh (Andrographispaniculata) is a native plant of India and Srilanka which has been widelyused as a natural remedy for common cold/ uncomplicated Upper Respiratory TractInfection (URTI). Its usefulness incommon cold has been shown by many studies and a meta-analysis of four RCTsdone (2004) showed that the difference in effect between A. paniculata andplacebo was 10.85 points (95% CI 10.36-11.34 points, P<0.0001) of thesymptom severity score in favour of A. paniculata. It is formulated asKalmcold / Ap-Bio.
In this clinical trial, we used objective measures and validated scalesto assess the efficacy of Kalmcold/AP-Bio, prepared from A. paniculataagainst uncomplicated URTI. The study was approved by the institutional ethicscommittee (EC/PHARMA-11/2019). We screened a total of n=331 participants and enrolledn=300 participants. They were randomized in a 1:1:1 ratio to three groupsnamely Kalmcold 200mg, Kalmcold 400mg and Placebo groups. The duration of allinterventions was for 7 days and the follow-up visits were done at day 3, day 5and day 7. A telephonic follow-up was done at 6 hours and day 2. The primary efficacy measure studied was(Wisconsin Upper Respiratory Tract Symptom score) WURSS-21. The study showedthat the intervention groups i.e., Kalmcold 200mg and 400mg groups showedsignificantly better resolution of symptoms of uncomplicated URTI when comparedwith placebo on Day 3. However, this difference is not maintained on day 5 andday 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting adults of any gender
- •60 years of age
- •Diagnosis of uncomplicated upper respiratory tract viral infection, onset of symptoms within 48 hours of randomization.
- •Not participated in any other interventional trials in the last 1 month before randomization
- •Participants with moderate to severe symptoms.
排除标准
- •Women of reproductive age who are pregnant / lactating / not willing for adequate contraception
- •History of allergy to any medications including alternate system of medications
- •Inability to follow-the protocol or expressed inability to complete all follow-ups
- •History of allergic rhinitis, asthma, serious ailments of the heart.
- •Liver or kidney, malignancies and any immunological disorders
- •History of any concomitant or chronic conditions involving the respiratory tract like bacterial pharyngitis, lower respiratory tract infections, Chronic obstructive pulmonary disease, interstitial lung disease, sinusitis etc.
- •Past history of Tuberculosis
- •User of any form of Tobacco everyday
- •Participants on medications / require any of the following medications – Antibiotics, Anti-viral agents, Anti-histaminics, Steroids, Decongestants, Herbal remedies, Vitamin C or Zinc.
结局指标
主要结局
Severity symptom score assessed by WURSS-21
时间窗: at baseline, 6 hours, days 2,3,5 & 7
次要结局
- Nasal mucosal weight and tissue paper count(Days 1, 2 and 3)
- Visual Analogue Score of symptoms (Cough , Expectoration , Nasal discharge , Headache , Fever Sore throat, Earache, Malaise/ Fatigue, Sleep disturbance ) From 0 to 100 : 0 being least and 100 being worst(at baseline, 6 hours, and twice daily afterwards till day 7)
- Adverse Event(through out the study)
- C reactive protein, WBC, nasal mucociliary function test, IL-8 & IgA in nasal wash(Baseline and day 3)