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Clinical study on WKF Syrup (Cough Syrup) in Cough

Evaluation of Efficacy and Safety of WKF Syrup in patients suffering from uncomplicated coughâ?? An Open Label, randomized, active comparative, multicenter, prospective, interventional clinical study - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042046
Enrollment
60
Registered
2022-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: R05- Cough

Interventions

Intervention1: WKF Syrup: WKF Syrup contains Adhatoda vasica, Zingiber officinale, Curcuma longa, Ocimum sanctum, Glycyrhiza glabra, Mentha arvensis. Dosage and Treatment Duration: 2 TSF of syrup two

Sponsors

Welex laboratories Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject suffering from uncomplicated cough that does not require antibiotic treatment 2. The onset time should not be more than 3 days 3. Willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Cough caused by bronchial asthma, tuberculosis, bronchiectasis, and other diseases that have been clearly diagnosed as chronic obstructive pulmonary disease and/or severe respiratory tract infection. 2. Patient with known current lung cancer and fibrosis of lung 3. Patients with uncontrolled diabetes or hypertension; 4. Subjects with known current serious illness, e.g., multisystem failure, chronic liver disease, HIV, cancer, renal failure, serious cardiovascular disease. 5. Women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial 6. Known allergy to any ingredient of study products 7. Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.

Design outcomes

Primary

MeasureTime frame
1.Comparative assessment of number of days required and number of subjects completely recovered from cough over a period of 14 days between the two groups 2.Comparative change in day and night frequencies of cough on a graded scale based on subject diary from baseline to end of therapy and between the two groups. Timepoint: Screening Visit (up to day 3), Baseline Visit (Day 0), Visit 1 Telephonic follow up (Day 4), Visit 2 (Day 7), Visit 3 Telephonic follow up (Day 10), Visit 4 (Day 14 or Complete resolution of Cough)

Secondary

MeasureTime frame
1. Comparative change in throat irritation on graded scale based on subject diary 2. Comparative change in sputum production on graded scale based on subject diary 3. Comparative assessment of requirement of rescue medications based on subject diary 4. Global assessment for overall change assessed by physician and subjects at the end of the study 5. Assessment of tolerability of study products by evaluating ADRs Timepoint: Screening Visit (up to day 3), Baseline Visit (Day 0), Visit 1 Telephonic follow up (Day 4), Visit 2 (Day 7), Visit 3 Telephonic follow up (Day 10), Visit 4 (Day 14 or Complete resolution of Cough)

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd.

targetinstitute@yahoo.com9322522252

Outcome results

None listed

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