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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.

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??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/07/004744
Enrollment
120
Registered
2014-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Cough

Interventions

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: 20m

Sponsors

SAVA Medical Ltd
Lead Sponsor

Eligibility

Inclusion 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

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 platelet counts 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactDr Badal Rathi

Sava Medica Ltd

badal.rathi@savaglobal.com9764449976

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026