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CTRI Number  CTRI/2020/09/027838 [Registered on: 16/09/2020] Trial Registered Prospectively
Last Modified On: 17/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to understand the effectiveness of a new product on adult subjects with cough.  
Scientific Title of Study   A double blind, single centric, randomized placebo-controlled study to demonstrate the efficacy and tolerability of an oral product in the management of symptoms of cough in comparison to placebo. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran N 
Designation  Principal Investigator 
Affiliation  Rajalakshmi Hospital 
Address  Rajalakshmi Hospital Department of Pulmonology Room Number-3 Ground Floor Lakshmipura Main Road Vidyaranyapura Post

Bangalore
KARNATAKA
560097
India 
Phone    
Fax    
Email  balaji.kiran.n@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Subramanian  
Designation  Chief Executive Officer  
Affiliation  Syncretic Clinical Research Services Pvt. Ltd 
Address  Syncretic Clinical Research Services Pvt. Ltd. No 32 Door No 4 (Old No.38) 5th cross 11th Main Vasanthnagar.

Bangalore
KARNATAKA
560052
India 
Phone    
Fax    
Email  deepa@syncretic.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian  
Designation  Chief Executive Officer  
Affiliation  Syncretic Clinical Research Services Pvt. Ltd 
Address  Syncretic Clinical Research Services Pvt. Ltd. No 32 Door No 4 (Old No.38) 5th cross 11th Main Vasanthnagar.

Bangalore
KARNATAKA
560052
India 
Phone    
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
Giellepi Spa Via B. Cellini, 37 20851 Lissone (MB) – Italy 
 
Primary Sponsor  
Name  Giellepi Spa 
Address  Via B, Cellini 37 Lissone (MB) - 20851 Italy  
Type of Sponsor  Other [Manufacturer, Limited Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran N  Rajalakshmi Hospital   Department of Pulmonology Room No2 Ground Floor Lakshmipura Main Road Vidyaranyapura Post
Bangalore
KARNATAKA 		 9164673490

balaji.kiran.n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pelargonium sidoides extract Malva sylvestris dry extract  Gummies with active ingredient has to be taken orally 3 times (morning, afternoon and night before sleeping) a day for 10 days. 
Comparator Agent  Placebo  Gummies with placebo has to be taken orally 3 times (morning, afternoon and night before sleeping) a day for 10 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patient should be able to give written informed consent.
2.Diagnosis of persisting cough (Cough Clinical Score of 3)
3.Males and females, 18-65 years of age (both inclusive)
4. Ability to comply with requirements of trial.
4.Persisting cough (at least 7 days up to 3 weeks, not treated with any antitussive product) 
 
ExclusionCriteria 
Details  Subjects having TB, COPD or Asthma, pulmonary fibrosis, lung cancer or chest X-ray showing lung problems.
2. Known history of drug or alcohol abuse.
3. Subjects who, in the opinion of the investigator, are mentally
incapacitated such that informed consent cannot be obtained.
4. Pregnant and lactating women.
5. Subjects with clinically significant history of co-morbid condition
(like, diabetes, immunodeficiency, HIV, HPV) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
6. Patients suffering from any condition which in opinion of the Investigator may interfere with the outcome for the study.
Subject with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease.
8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values ≥ 2.5 X Upper Limit of Normal (ULN), Serum creatinine of ≥ 1.5 mg/dL.
9. Subjects on Hormone replacement therapy or chemotherapy or radiotherapy.
10. Subjects participating in any other studies or participated in any clinical trial 3 months prior to start of this trial.
11. Known hypersensitivity to, or intolerance of, study products or their formulation excipients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate that Investigational product is more effective than placebo for the management persisting cough. An improvement of 2 score (Cough Clinical Score) is expected in 25% of subjects treated with investigational product.  Screening Day 0 Day 5 and Day 10 
 
Secondary Outcome  
Outcome  TimePoints 
improvement of day-time cough score from between active and placebo.
Change in LCQ in between groups
Change in Leicester Cough Questionnaire in between active and
placebo and in between groups.
Change in cough using VAS between active and placebo.
Change in nocturnal cough and sleep quality between active and placebo.
Change in short Form 36 item (SF36)
Compliance and tolerability.
Overall treatment satisfaction questionnaire. 		 Screening Day 0 Day 5 and Day 10 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 22/09/2020 
Date of Study Completion (India) 19/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="20" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This clinical trial is being planned to assess the efficacy and safety of a new product when compared to placebo in the treatment of cough in adults. 40 subjects with cough will be recruited into the trial and the trial will be for a period of 10 days from the day of randomisation. 
The treatment will observe the improvement in day time score with the help of questionnaire, change in Leicester cough questionnaire, Change in cough using VAS and change in nocturnal cough and sleep quality on Day 0, day 5 and day 10. 
The objective of this study is to access the efficacy and safety of the investigational product in adult subjects with cough. 

Type of the study - Randomized, double blind, placebo controlled 
 
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