Effect of the herbal EMCOF cough syrup for cough control.

Phase 3

Completed

Brief Summary: The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 50 participants will be randomized in tos ingle group.Dosing will be done daily orally twice or thrice daily for 5-7 days. Subjects will be asked to visit clinical facility/ institution for their follow up at the end of day 2 , day 5 and day 7 and any other additional visits if needed.

Primary and Secondary Outcome

1) Change in daytime Cough symptom scores

2) Change in Night time Cough Symptom

3) Reduction of Pharyngeal pain

4) VAS Score

5) Proportion of patients having a confirmed Best Response or partial Response or Complete Response

6) To assess quality of Life using Leicestar Cough Questionnaire (LCQ-acute)

Recruitment & Eligibility

Inclusion Criteria

Patients willing to provide written informed consent to participate in the study 2.
Male and Female patient in the age range of 10-65 years.
Patients with acute and Chronic,Productive or non-productive cough (Dry cough, Wet cough, Asthmatic cough, Allergic cough, Infective cough, Smokers cough, Sore throat, Hoarse cough, Ratting / Tickling cough) presenting in out patient setting.
Patients with a baseline daytime cough symptom score of at least 2.

Exclusion Criteria

Female patient who is pregnant or lactating.
Patients or with clinically suspected lower respiratory tract infection (e.g. pneumonia tuberculosis) 3.
Patients taking any other antitussives, sleeping pills, sedative medications, or herbal cough remedies; 4.
Patients currently on any treatments that may influence cough.
Patient has history of hepatic or renal insufficiency 6.
Any condition decided as unfit for study by Clinical investigator.

Primary Outcome Measures

Name	Time	Method
1)Change in the daytime cough symptom scores and cough rating scale at end of 5 days (120 hrs) of first examination as compared to the baseline	Day 0, Day 2, Day 5 and Day 7
2. Change in Night time cough symptom scores and cough rating scale from the baseline to end of 5 days (120 hrs) of first examination as compared to the baseline	Day 0, Day 2, Day 5 and Day 7
3. Reduction of pharyngeal(throat) pain(if present) before and at the end of 5 days- measured on Visual Analogue Scale (VAS) . [time frame: 5 days]	Day 0, Day 2, Day 5 and Day 7
4. Use of rescue medication (Cough syrup). [time frame: 10 days]	Day 0, Day 2, Day 5 and Day 7
5. Proportion of patients having a confirmed Best response or Partial Response or Complete response (10 days duration)	Day 0, Day 2, Day 5 and Day 7
6. To assess the quality of life among the study participants using pre and post Study Leicester Cough Questionnaire (LCQ-acute)	Day 0, Day 2, Day 5 and Day 7
Adverse events and serious adverse events during the study period	Day 0, Day 2, Day 5 and Day 7
Brief clinical examination	Day 0, Day 2, Day 5 and Day 7

Secondary Outcome Measures

Name	Time	Method
1)To demonstrate safety and tolerability of study product by Clinical AEs (If any)	2)Proportion of patients having a confirmed Best response or Partial Response Or Complete response (10 days duration)

Locations (1): Thirumalai Medical Centre, Puducherry
🇮🇳
Pondicherry, PONDICHERRY, India
Thirumalai Medical Centre, Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Dr M Sakthi Balan
Principal investigator
9443627722
saheerose@gmail.com