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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/07/004744
• Date of registration: 16-07-2014
• Prospective Registration: No
• Primary sponsor: SAVA Medical Ltd
• Public title: 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.
• Scientific title: 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??
• Date of first enrolment: 15-07-2014
• Target sample size: 120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9562
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Badal Rathi
• Affiliation: Sava Medica Ltd

• Name: Dr Badal Rathi
• Affiliation: Sava Medica Ltd

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Acute Cough

Intervention(s)

Intervention1: RANKOF Herbal Syrup: Dose: 20ml per Day

Frequency: twice a day (10ml BD)

Duration: Min.4 days to Maximum 8 days

Route of administration: Oral
Control Intervention1: Adulsa: Dose: 20ml per Day

Frequency: twice a day (10ml BD)

Duration: Min.4 days to Maximum 8 days

Route of administration: Oral

Primary Outcome(s)

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(s)

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).



Telephonic Follow up after 30days of EOT.

Secondary ID(s)

01/RANKOF/SAVA/2014

Source(s) of Monetary Support

SAVA Medica Ltd, Viman Nagar, Pune 411014, MH,India

Ethics review

Status: Approved
Approval date: 18/06/2014
Contact:

Royal Pune Independent Ethics Committee

Status: Approved
Approval date: 24/06/2014
Contact:

Nagpur Independent Ethics Committee