| CTRI Number |
CTRI/2022/05/042564 [Registered on: 13/05/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study to Evaluate Efficacy and Safety of Curkey pastille with standard treatment in acute, viral,URTI and in combination with standard antibiotic in bacterial URTI and compared with standard antibiotic treatment alone in children of 7-12 years of age. |
|
Scientific Title of Study
|
"Open Label, Comparative, Randomized, clinical study to evaluate efficacy and safety of Curkey Pastilles when taken with standard treatment in acute, viral, uncomplicated, upper respiratory tract infection and in combination with standard antibiotic in acute uncomplicated bacterial upper respiratory tract
infection and compared with standard antibiotic treatment alone in children of
7-12 years of age." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumitra Venkatesh |
| Designation |
Doctor |
| Affiliation |
Bai Jerbai Wadia Hospital for childrens |
| Address |
Bai Jerbai Wadia Hospital for chilldrens OPD no 5/6, Achary Donde marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820186541 |
| Fax |
0 |
| Email |
sumitravenkatesh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitra Venkatesh |
| Designation |
Doctor |
| Affiliation |
Bai Jerbai Wadia Hospital for childrens |
| Address |
Bai Jerbai Wadia Hospital for chilldrens OPD no 5/6, Achary Donde marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820186541 |
| Fax |
0 |
| Email |
sumitravenkatesh99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra Venkatesh |
| Designation |
Doctor |
| Affiliation |
Bai Jerbai Wadia Hospital for childrens |
| Address |
Bai Jerbai Wadia Hospital for chilldrens OPD no 5/6, Achary Donde marg Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820186541 |
| Fax |
0 |
| Email |
sumitravenkatesh99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Inzpera Health Sciences Limited.407, Summit Business bay, off.Andheri Kurla road, near WEH metro station, Andheri East, Mumbai, 400093, Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Inzpera Healthsciences Limited |
| Address |
407 Sumit Buisiness Bay, off Andheri- Kurla Road Andheri |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumitra Venkatesh |
Bai Jerabai Wadia Hospital for chilldrens |
Bai Jerbai Wadia Hospital for chilldrens OPD no 5/6, Achary Donde marg Parel Mumbai
Mumbai
MAHARASHTRA |
9820186541
0
sumitravenkatesh99@gmail.com |
| Dr Nayan Patel |
Neighbourcare TM Multispecialty OPD clinic |
Shop co2 Pinecrest building
North Avenue Godrej Garden City
Ahemedabad 382481
Gujarat India
Ahmadabad
GUJARAT |
9909013286
0
dr.nayan@neighbourcare.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee |
Approved |
| Bai Jerbai Wadia Hospital for Children |
Approved |
| Bai Jerbai Wadia Hospital for Children |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Curkey Pastille, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 100(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Amoxicilin | Amoxicillin 40 mg /kg/day, 20mg twice a day(BD) for 5 days. |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Parents or legal guardians willing to sign written informed consent form for the child and child willing to sign assent form for participation
2. Children and parents / guardians who agree to comply with study requirement and schedule Diagnosed uncomplicated acute infectious and inflammatory diseases of the pharynx, accompanied by a sore throat;
3. Should be more than 7 years of age and less than or equal to 12 years of age at the time of inclusion into the study;
4. Onset of first symptoms of the uncomplicated acute infectious and inflammatory diseases of the pharynx (pharyngitis and/or tonsillitis) less than 48 hours prior to inclusion into the study;
5. Tonsillopharyngitis Severity Score (TSS) ≥ 5 (TSS consist of sore throat, dysphagia, secretions and erythema). Baseline modified Centor score ≤ 2 (total score)
6. Subjects with throat symptoms and fever on patient reported outcome measures: sore throat pain rated more than or equal to 66 mm on the Sore Throat Pain Intensity Scale (STPIS) and fever more than 98.60 F
|
|
| ExclusionCriteria |
| Details |
1. Use of analgesics within <12 hours prior to the study start or/and inability to cancel them during the study;
2. Use of antibiotics within <48 hours prior to the study start or/and inability to cancel them during the study;
3. Use systemic or inhaled corticosteroids within ≤1 months prior to the study start and planned therapy of them during the study (besides skin means).
4. Subjects presenting with bronchitis, severe pharyngitis, severe tonsillitis
5. Highly infected and inflamed tonsillitis pediatric patients.
6. Subjects with any other chronic illness such as asthma, heart blocks, any congenital anomaly
7. Subjects having sensitivity reaction to components of Curkey or antibiotics suggested in the reference group.
8. Subjects will be ineligible if they displayed confounding features of URTI: mouth breathing which causes throat drying, coughing which causes throat discomfort, or any disease that could compromise respiratory function.
9. Subjects will be also ineligible if they had a history of allergic reaction or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs, or any gastrointestinal, hepatic, or renal dysfunction.
10. Subjects will be excluded if they had to use any throat lozenge, throat spray, cough drop, or menthol-containing product within one hour prior to study screening, used any ‘cold medication’ or immediate release analgesic within the previous four hours, used any sustained-release analgesic within the previous 12 hours, taken an antibiotic for an acute disease within 24 hours, or any quinolone antibiotic or inhaled therapy in the previous week.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy Endpoint(s)
Efficacy will be evaluated based on the following parameters comparing intra-patients for Group A and the two treatment arms from baseline to end of treatment for Group B
1. Proportion of subjects with reduction of Tonsillopharyngitis Severity Score [TSS 50%]
2. Global assessment of efficacy
3. Visual analog [VAS] scale
4. Modified Centor Scale[MCS]
5. Tonsillo-Pharyngitis Assessment [TPA] scale
 
|
Base line, 3rd day, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the Safety of Curkey® when administered with standard
treatment in acute, viral, uncomplicated upper respiratory tract infection in
children of 7-12 years of age
|
1st day, 3rd day, 5th day |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 4 |
|
Date of First Enrollment (India)
|
17/05/2022 |
| 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="0"
Months="6"
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
Modification(s)
|
Upper respiratory tract infections (URTIs) are believed to be one of the main reasons for visits to the pediatrician and are considered the most common reason for absenteeism from school. URTIs include but are not limited to laryngitis, pharyngitis, tonsillitis and acute rhinitis. Most URTIs have a viral origin but may also be caused by bacteria. Allergies, air pollution, shouting or speaking loudly can cause mild inflammation of the respiratory tract, which may lead to chronic disorders if not treated early. Viral URTIs resolve spontaneously and do not require antimicrobial intervention unless complicated by acute otitis media with effusion, tonsillitis, sinusitis, and lower respiratory tract infection. Group A beta-hemolytic streptococcus (GABHS) accounts for 15 to 30 percent of cases of acute pharyngitis in children. Though URTIs are generally self-limiting, antibiotics are often prescribed to prevent suppurative and non-suppurative complications. However, an alarming rise in antibiotic resistance in past decades has prompted research in alternative therapies. Traditional remedies like gargling with salt water or consumption of turmeric milk are recommended butare not child friendly and provide temporary relief. It is thus prudent to identify solutions that shall provide quick and localized symptomatic relief with minimal side effects in a child friendly formulation. Curcuma longa rhizome has been traditionally used as antimicrobial agent1. Severalstudies have reported the broad-spectrum antimicrobialactivity for curcumin including antibacterial, antiviral, antifungal,and antimalarial activities. Because of the extendedantimicrobial activity of curcumin and safety property evenat high doses (12 g/day) assessed by clinical trials in human,it was used as a structural sample to design the new antimicrobialagents with modified and increased antimicrobialactivities through the synthesis of various derivatives relatedto curcumin |