A Randomized Double Dummy Double Blind Dose Determining Place-bo Controlled Study to Evaluate Efficacy of Investigational Product E-RH-06 at 2 Dose Levels for the Metabolic Management of Chronic or Recurrent, Non-infective Nasal Congestion With-or-without Rhinorrhea.
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 8
- 主要终点
- TNSS Score
研究概览
简要总结
The study will be conducted in two phases. First phase will be 16 weeks study to assess the safety, efficacy & to determine the most appropriate dose. Will consist of following visits.
Phase II (Extended Follow-up): At the end of Day 112, an interim analysis will be conducted to assess the sustained efficacy of the investigational product and accordingly the study will enter into phase II.
详细描述
The study will be conducted in two phases. First phase will be 16 weeks study to assess the safety, efficacy & to determine the most appropriate dose. Will consist of following visits:
Screening I (Day -14) Visit: After obtaining written informed consent, subjects will be screened for study eligibility as per the inclusion/exclusion criteria defined in the study protocol on screening visit. The screening evaluations will include general examination, medical history taking, recording of vital parameters and assessment of frequency of symptoms, and Total Nasal Symptom Score (TNSS) calculation. Blood sample will be collected for CBC, SGPT & Urine creatinine analysis. Simultaneously urine samples will be collected for urine routine & UPT analysis. ECG will be performed.
Screening II (Day -7) Visit: Laboratory results and ECG reports will be analysed by the investigator. Eligible subjects will be entered into 7 days run-in period. Rescue medication will be dispensed.
Baseline Visit/ Randomization Visit (Week 0): At the end of screening period (Baseline visit, window period + 3 days), subjects fulfilling the rhinitis frequency and symptom criteria (baseline average scores as: average 24-h TNSS 10 over 15 days, and requiring no more than 2 tablets of rescue medication (Loratidine) daily to control the symptoms) will be randomized to one of the 3 treatment groups to receive the following treatment regimens:
- Group 1: E-RH-06/ 1 BID: (E-RH-06 + Placebo) Twice Daily
- Group 2: E-RH-06/ 2 BID: (E-RH-06 + E-RH-06) Twice Daily
- Group 3: Placebo: (Placebo + Placebo) Twice Daily Rescue medication accountability & dispensing will be performed. Specially designed rescue medication charts will be dispensed. Subjects will be provided with subject diaries. Vitals & general examination will be performed. TNS scoring will be performed. IP/ Placebo will be dispensed. IP accountability will be performed. Adverse event & serious adverse event monitoring will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects in the age group of 18-60 years with per-sistent or recurrent nasal congestion and/ or rhinorrhea as defined by the symptoms that last for not less than an hour.
- •Demonstrating baseline average 24 hour TNSS ≥
- •No clinical evidence of infection indicated by mucopurulent or puru-lent discharge, fever, and tenderness over paranasal sinuses.
- •Subjects who will be able to read and fill-up subject diary efficiently.
- •Able and willing to give informed consent.
- •Able and willing to follow all study related instructions and to make all required visits.
排除标准
- •Subjects who have taken systemic, topical corticosteroids, long acting antihistamines or immunosuppressive medication within last 4 weeks or planning to take them within the course of the study.
- •Acute febrile illness (such as cold, flu etc.) within one week of enroll-ment.
- •Subjects with nasal structure deformities, nasal polyps, severe deviat-ed nasal septum and hypertrophic rhinitis will be excluded from the study.
- •Clinical history of allergy/ hypersensitivity to one or more products of herbal origin.
- •Pregnant / lactating women and women who are planning to get preg-nant
- •Recent (within last 3 months) participation in a clinical trial
- •Recent (within last 15 days) use of any herbal product for the indication under study
- •Patients with severe conditions of chronic sinusitis deviated nasal sep-tum or nasal polyposis.
- •Bronchial asthma patients on loading/ maintenance therapy of theophy-line.
- •Patients requiring continuous use of laxatives.
- •Major chronic disease of liver, kidney, CVS or CNS and other body systems
- •A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance.
- •Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study.
研究组 & 干预措施
E-RH-06 - Low Dose
1 Capsule twice daily
干预措施: E-RH-06 (Dietary Supplement)
E-RH-06 - High Dose
2 capsules twice daily
干预措施: E-RH-06 (Dietary Supplement)
Placebo ;
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
TNSS Score
时间窗: 12 weeks
To determine if the investigational product E-RH-06 relieves the symptoms of nasal congestion with-or-without rhinorrhea to a greater extent than placebo with 12 weeks' treatment as assessed by the pre-visit 24 hours reflective TNSS
次要结局
- Reduction of frequency(4 weeks)