| CTRI Number |
CTRI/2023/06/053472 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Trial to assess efficacy of Curcunan® in the management of upper respiratory tract infection |
|
Scientific Title of Study
|
A prospective, randomized, double-blind study to evaluate the efficacy of Curcunan® on Upper Respiratory Tract Infections (URTIs) and its recurrence along with its effect on immunity. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR0087-008 V1.0 Dated 05 April 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghana Murthy |
| Designation |
Consultant General Medicine |
| Affiliation |
Vagus Super Speciality Hospital |
| Address |
Room number 11, Vagus Super Speciality Hospital
Room Number 11 #6, 7 & 8, 18th Cross, 4th Main Road, Malleshwaram,
Bangalore
KARNATAKA
560055
India |
| Phone |
7259214727 |
| Fax |
|
| Email |
meggydoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujay Gowda |
| Designation |
Head Clinical Development |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Building No 06, 3rd and 4th floor,2nd Main Rd, Sarvobhogam Nagar,
Arekere, Bengaluru Landmark: Opposite to British Biologicals
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9110224495 |
| Fax |
|
| Email |
sujay.gowda@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
VP-Business Operations |
| Affiliation |
Syncorp Health Pvt Ltd |
| Address |
Building No 06, 3rd and 4th floor,2nd Main Rd, Sarvobhogam Nagar,
Arekere, Bengaluru Landmark: Opposite to British Biologicals
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
9742172953 |
| Fax |
|
| Email |
subham.dutta@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Sushrutha Ayurvedic Medical College and Hospital
Prashanti Kuteera, Jodi Bingipura, Jigani Hobli, Anekal, Taluk,
Bengaluru- 560105 , Karnataka, India |
| Vagus Super Speciality Hospital
#6, 7 & 8, 18th Cross, 4th Main Road, Malleshwaram, Bengaluru– 560055, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr. Willmar Schwabe India Pvt. Ltd. |
| Address |
36, Sector 60, Noida,
U.P. - 201304, India.
|
| Type of Sponsor |
Other [Health Functional Food] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubha Rani M |
Sushrutha Ayurvedic Medical College and Hospital |
Prashanti Kuteera, Jodi Bingipura, Jigani Hobli, Anekal, Taluk,
Bengaluru- 560105 , Karnataka, India
Bangalore
KARNATAKA |
9449453674
dr.shubharani111@gmail.com |
| Dr Meghana Murthy |
Vagus Super Speciality Hospital |
Room Number 11 #6, 7 & 8, 18th Cross, 4th Main Road, Malleshwaram, Bengaluru– 560055, Karnataka, India
Bangalore
KARNATAKA |
7259214727
meggydoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Vagus Institutional Ethics Committee |
Approved |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J393||Upper respiratory tract hypersensitivity reaction, site unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcumin |
Curcunan® is an extract obtained from Curcumin longa. The curcumin extract contains 95% Curcuminoids and Tetrahydro curcuminoids. It is a 500 mg capsule which will be consumed twice a day, orally, from baseline to day 90. |
| Comparator Agent |
Placebo |
MCC – Microcrystalline cellulose.
It is a 500 mg capsule which will be consumed twice a day, orally, from baseline to day 90. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female participants aged 18-50 (both ages inclusive)
2. Participants with a BMI ≥18.5 and ≤ 30.0 kg/m2.
3. Suffering from URTI i.e., at least 6 URTIs episodes medically confirmed, with a maximum of 12 within 1 Year before the study and must be presenting with the below symptoms of URTI (< 2 days of onset):
i) Runny nose/Nasal congestion
ii) Headache
iii) Low-grade fever
iv) Sneezing.
4. Participant must be able & willing to comply with study procedures.
5. Participant willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1. Known sensitivity to the investigational product or any excipients of the drug product.
2. Persistent fever more than 1020F.
3. Signs of acute lower respiratory tract disease.
4. Current symptoms are mainly induced by other acute ENT diseases.
5. Daily use of antibiotics, steroids, and cytotoxic agents.
6. Patients on active treatment from any other system of medicine.
7. Patients with any uncontrolled systemic disease, infection, and any organ failure.
Severe co morbidity including previous malignant disease during the past 3-year prior enrolment.
8. Severe or complicated course of URTI (stridor, laryngomalacia, etc.)
9. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
10. Subjects with COVID infection in the last 30 days.
11. Abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapor rub, etc.
12. Presence of uncontrolled type 2 diabetes and hypertension.
13. Vaccination against influenza or swine flu within 3 months prior to screening
14. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDS (paracetamol) or other medications that are expected to alleviate cold symptoms within two weeks prior to randomization.
15. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study’s end points.
16. Participation in other clinical trials in the last 30 days prior to screening.
17. Participants with 3 months history of chronic smoking, alcohol, or drug abuse.
18. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
19. Any condition that could, in the opinion of the investigator, preclude the participant’s ability to complete the study successfully and safely or that may confound study outcomes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in quality of life by WURSS-21 questionnaire in comparison to placebo
2. Change in hs-CRP in comparison to placebo.
3. Change in Erythrocyte Sedimentation Rate (ESR) in comparison to placebo.
4. Change in the severity of Symptoms of URTI episodes as analyzed by WURSS-21 Questionnaire in comparison to placebo.
5. Number of days with fever using patient diary in comparison to placebo.
6. Duration of usage of any rescue medication using patient diary in comparison to placebo.
7. Unscheduled visits to physicians using patient diary in comparison to placebo.
8. Absence from work using patient diary in comparison to placebo.
9. Hospital admissions (number of days in the hospital and number of hospitalization) using patient diary in comparison to placebo |
1. Every day for 10 days during demonstration of symptoms at each episode throughout the study.
2. Day 1, Day 10, and Day 90.
3. Day 1, Day 10, and Day 90.
4. Throughout the study.
5. Throughout the study.
6. Throughout the study.
7. Throughout the study.
8. Throughout the study.
9. Throughout the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Vitals (Blood pressure, body temperature and pulse rate)
2. Complete Blood Count [Haematology-WBC count, RBC count, haemoglobin, haematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes)]
3. Urine Analysis (pH, ketone bodies, nitrite, colour, appearance, specific gravity)
4. AE/SAE |
1. Screening, Day 1 (Baseline), Day 10, Day 45, Day 90, And Day 120.
2. At time points: Day 1 and Day 90.
3. At time points: Day 1 and Day 90
4. Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2023 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is a randomized, double-blind placebo-controlled study to assess the efficacy
and safety of Curcunan® in the management of Upper Respiratory Tract Infection (URTI). The study
will be conducted in male and female patients between the ages of 18-50 years
(inclusive of both the ages). Screening data will be reviewed to determine participant’s
eligibility. Patients who meet all inclusion criteria and exclusion criteria
will be enrolled in the clinical study.
A
total of 64 participants will be enrolled in the clinical study and randomized
into either of the 2 groups in the ratio of 1:1, Group A: Curcunan® and Group B: Placebo. Each enrolled patient
will receive their respective IP, as per the randomisation, from baseline till
day 90. Patients will visit the site for a follow up visit on Day 10 (±3 days),
Day 45 (±3 days), and Day 90 (±3 days). Also, a telephonic follow up will be
done on day 30 and day 60 for any recurrence of URTI episodes. For the increase
in the severity of the symptoms and for any recurrence of the URTI, the
patients will be prescribed rescue medication (Cetirizine 5mg + Paracetamol
325mg + Phenylephrine 10mg BD) as per the discretion of the investigator. The
duration and frequency of the rescue medication will be captured in the CRF and
patient diary.
On
day 90 (±3 days) (Visit 4), the patient will stop consuming the IP. A
telephonic follow up will be done on day 105 for safety and recurrence of URTI
episodes. Patients will visit site on Day 120 (±3 days) for follow up. |