| 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
|
|
|
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 |