â??An Open label, Observational, Multicentre, Parallel Group two Arm Randomized Study to Evaluate the Efficacy and Safety of the RANKOF Herbal Syrup Versus ADULSA Herbal Syrup for Symptomatic Relief of Acute Cough and Throat Irritationâ??

SAVA Medical Ltd0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Male and females between 18 to 65 years age.
•2. Patients diagnosed as Acute cough having history less than 2 weeks.
•3. Patient willing and able to provide a signed written informed consent prior to any study â??specific procedure.
•4. Patients who in opinion of the investigator will be able to comply with the study requirements.

•1. Subjects on any other herbal therapy / supplement for cough
•2. Subjects living too far from the participating center or unable to return for follow-up visits.
•3. Patients with hepatic impairment (SGOT or SGPT levels > 3 x Upper
•Limit of Normal (ULN)) or renal impairment (serum creatinine
•1.5mg/dl) or
•known hematopoietic disorder (absolute leukocyte count < 4000/lL,
•platelet counts < 100,000/lL, hemoglobin level < 9.0 g/dL).
•4. Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization).
•5. Patients with known history of hypersensitivity to the study drug.
•6. Patients with continuing history of alcohol / Tobacco and / or drug abuse.
•7. Patients with any other serious concurrent illness or malignancy.
•8. Participation in another clinical trial in the past 3 months
•9. Patient with any blood donation in past one month
•10. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection
•11. Acute bacterial, fungal or viral infection

发起方

SAVA Medical Ltd