A clinical trial is to study the safety and efficacy of the RANKOF herbal syrup in comparison with Adulsa herbal syrup in patients with acute cough.

Not Applicable

Completed

Conditions: Health Condition 1: null- Acute Cough

Registration Number: CTRI/2014/07/004744

Lead Sponsor: SAVA Medical Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the non inferiority of RANKOF herbal syrup compared with ADULSA Herbal Syrup with respect to symptomatic relief in patient suffering from cough.Timepoint: with in 24 hrs after completion of EOT (End of the Treatment).

Secondary Outcome Measures

Name	Time	Method
Secondary objectives ï?· To determine the efficacy of RANKOF herbal syrup compared with ADULSA Herbal Syrup with respect to symptomatic relief in patient suffering from cough ï?· To determine the safety and efficacy of RANKOF herbal syrup compared with ADULSA Herbal Syrup with respect to symptomatic relief in patient suffering from cough ï?· To evaluate the efficacy of RANKOF herbal syrup compared to ADULSA Herbal Syrup with respect to PFTTimepoint: with in 24 hrs after completion of EOT (End of the Treatment). <br/ ><br> <br/ ><br>Telephonic Follow up after 30days of EOT.