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CTRI Number  CTRI/2021/08/036075 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 02/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Cistus Plus Infektblocker, Gum Arabic lozenges, and Cistus Echinacea Lozenges in patients with sore throat 
Scientific Title of Study   A single blind, randomized, comparative prospective clinical study to evaluate the efficacy of a Cistus Plus Infektblocker, Gum Arabic lozenges, and Cistus Echinacea Lozenges in patients with sore throat due to bacterial or viral infection. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NUTRIN009 Version 1.1 Dated 05 May 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Puneet Mittal 
Designation  Director Clinical Research 
Affiliation  Mittal Global Clinical Trial Services 
Address  Dept. Of Clinical Research, First Floor, 121B, Mansarovar INDL. EST. EXT., Inside Vishvakarma IND. EST. Panchli, Baghpat Rd, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  8937015757  
Fax    
Email  puneetmittal@mgcts.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhijit Munshi 
Designation  Director Clinical Operations 
Affiliation  MITTAL GLOBAL CLINICAL TRIAL SERVICES 
Address  Dept. Of Clinical Research, First Floor, 121B, Mansarovar INDL. EST. EXT., Inside Vishvakarma IND. EST. Panchli, Baghpat Rd, Meerut

Meerut
UTTAR PRADESH
250005
India 
Phone  8937045757  
Fax    
Email  drabhijit@mgcts.org  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijit Munshi 
Designation  Director Clinical Operations 
Affiliation  MITTAL GLOBAL CLINICAL TRIAL SERVICES 
Address  Dept. Of Clinical Research, First Floor, 121B, Mansarovar INDL. EST. EXT., Inside Vishvakarma IND. EST. Panchli, Baghpat Rd, Meerut

Baghpat
UTTAR PRADESH
250005
India 
Phone  8937045757  
Fax    
Email  drabhijit@mgcts.org  
 
Source of Monetary or Material Support  
Alsitan GmbH, Gewerbering 6, 86926 Greifenberg, Germany 
NUTRIN GmbH, Schnaid 36B, 91352 Hallerndorf, Germany 
 
Primary Sponsor  
Name  NUTRIN GmbH 
Address  Schnaid 36B, 91352 Hallerndorf, Germany 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Alsitan GmbH  Gewerbering 6, 86926 Greifenberg, Germany 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Avinash Wachasundar  AMFs Moraya Multispeciality Hospital  department of Pulmonology, Ground Floor, Opp. PMP bus Stop, Powerhouse Chowk, Chinchwadgaon, Pune 411033
Pune
MAHARASHTRA 
9822046072

avinashwacha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Moraya Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J02||Acute pharyngitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cistus Echinacea Lozenges  5-6 lozenges a day, oral use, upto 5 days 
Intervention  Cistus Plus Infektblocker  5-6 lozenges a day, oral use, upto 5 days 
Comparator Agent  Gum Arabic lozenges  5-6 lozenges a day, oral use, upto 5 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects of either sex
2. Male or female aged from18 to 65years
3. Patient with sore throat due to viral or bacterial infection.
4. Are free of any disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
6. Are able to give written informed consent in a manner approved by the Institutional Ethics Committee and comply with the requirements of the study.
7. Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
8. Compliance by the patient seems guaranteed, and the patient seems to be able to understand and complete the patient diary. 
 
ExclusionCriteria 
Details  1. Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
2. Covid-19
3. Oro-pharyngeal paresthesia or mycosis
4. Severely traumatized and/or very severe oromucosal inflammation
5. Tonsillo-pharyngectomy
6. Peritonsillar abscess
7. Allergic to Cistus, Echinacea, elderberry, gum Arabic
8. Long term use (≥ 3 times per week within the last month or regular intake within the last
3 months before randomization) of anti-inflammatory drugs- Any long-acting or slow release analgesic intake including Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomization (e.g. piroxicam or naproxen)
9. Any anti-inflammatory drugs intake by systemic route within 12 hours before randomization
10. Any paracetamol intake within 6 hours before randomization
11. Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomization
12. Any topical throat medication intake containing or not a local oral anesthetic such as lozenge, spray, mouth rinse within 4 hours before randomization
13. Heavy smokers (>20 cigarettes/day) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Cistus Plus Infektblocker Lozenges, Gum Arabic Lozenges and Cistus Echinacea Lozenges for throat infection/pharyngitis  Baseline and Day 05 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the safety and tolerability  Baseline and Day 05 
physical Layer effect of Lozenges  Baseline 
 
Target Sample Size   Total Sample Size="267"
Sample Size from India="267" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
A throat infection, sometimes called pharyngitis, can be either a bacterial or a viral infection leading to inflammation of the tissues of the throat that causes redness, pain and swelling of the walls or structures of the throat. The throat, or pharynx, is the tube-like structure that carries both food to the oesophagus and air to your windpipe (called the larynx). Infective agents of the throat most often enter through the mouth or nose. Many of these infections are viral; others can be caused by bacteria (such as Streptococcus pyogenes, or group A Streptococcus). Symptoms of throat infection most commonly include pain and a sensation of heat in the throat or pharynx. Viral Infections account for approximately 70% of all pharyngitis. Rhinovirus is the most common cause of viral infection. The other common causes of viral infection in descending order are coronavirus, adenovirus, parainfluenza, and influenza virus. Viral infections are more common during the winter months with the exception of adenoviruses which occur year round. Viral pharyngitis is spread through similar mechanism as other viral infections. Hand to mouth contact, contact with oral secretions and sharing common utensils all contribute to viral spread. Prevention of the spread of disease is based on frequent hand washing and Clinical symptoms of different viruses are more prevalent during certain seasons. Coryza, conjunctivitis, malaise or fatigue, hoarseness, and low-grade fever suggest the presence of viral pharyngitis.Subjects with viral pharyngitis can also have atypical symptoms such as mouth breathing, nausea, vomiting, abdominal pain and diarrhoea. 

A throat lozenge (also known as a cough drop or cough sweet) is a small, typically medicated tablet intended to be dissolved slowly in the mouth to temporarily stop coughs, lubricate, and soothe irritated tissues of the throat (usually due to a sore throat).On a clinical level, Cistus is beneficial in respiratory infections mainly caused by virus and bacteria. Cistus-Infektblocker are fruity sugar-free lozenges with rock rose extract, elderberry extract and gum arabic. Like a protective shield, the polyphenols (tannins) from the plant extract (Cistus / Echinacea extract) spread over the oral and pharyngeal mucous membranes and thus help to ward off viruses and bacteria before they enter the body. Due to the physical mode of action, there is no development of resistance. These standardized special extracts enable a high effective dosage of polyphenols. Gum arabic relieves dry coughs
 
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