| CTRI Number |
CTRI/2019/10/021754 [Registered on: 22/10/2019] Trial Registered Prospectively |
| Last Modified On: |
03/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Whether an ayurvedic drug preparation named Ap-Bio/Kalmcold is safe and effective when used to treat participants diagnosed with common cold and have no other complications |
|
Scientific Title of Study
|
Efficacy and safety of Ap-Bio/Kalmcold in participants with uncomplicated upper respiratory tract viral infection (common cold) - A Phase III, double-blind, parallel group, randomized placebo-controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nithya gogtay |
| Designation |
Professor |
| Affiliation |
Seth GSMC & KEM Hospital |
| Address |
Dept. of Clinical Pharmacology
1st Floor, New Building
Seth GSMC & KEM Hospital
Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224133747 |
| Fax |
|
| Email |
njgogtay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeffrey Pradeep Raj |
| Designation |
Senior Resident |
| Affiliation |
Seth GSMC & KEM Hospital |
| Address |
Dept. of Clinical Pharmacology
1st Floor, New Building
Seth GSMC & KEM Hospital
Parel.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
07904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeffrey Pradeep Raj |
| Designation |
Senior Resident |
| Affiliation |
Seth GSMC & KEM Hospital |
| Address |
Dept. of Clinical Pharmacology
1st Floor, New Building
Seth GSMC & KEM Hospital
Parel.
Osmanabad
MAHARASHTRA
400012
India |
| Phone |
07904286189 |
| Fax |
|
| Email |
jpraj.m07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Natural Remedies Private Limited
Plot No. 5B, Veerasandra Indl. Area,
19th K. M. Stone,
Hosur road, Electronic City Post,
Bangalore, 560100.
Karnataka,
India. |
|
|
Primary Sponsor
|
| Name |
Natural Remedies Private Limited |
| Address |
Plot No. 5B, Veerasandra Indl. Area,
19th K. M. Stone,
Hosur road, Electronic City Post,
Bangalore, 560100.
Karnataka,
India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeffrey Pradeep Raj |
Seth GS Medical College & King Edward memorial Hospital |
Acharye Donde Marg, Parel, Mumbai
Mumbai
MAHARASHTRA |
7904286189
jpraj.m07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ap-Bio/Kalmcold (low dose) |
100 mg twice daily orally after food for 7 days |
| Intervention |
Ap-Bio/Kalmcold (moderate dose) |
200mg twice daily orally after food for 7 days |
| Comparator Agent |
Placebo |
twice daily orally after food for seven days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting adults of any gender 18 - 60 years of age
2. Diagnosis of uncomplicated upper respiratory tract viral infection, onset of symptoms within 48 hours of randomization.
3. Not participated in any other interventional trials in the last 1 month before randomization
4. Participants with moderate to severe symptoms
|
|
| ExclusionCriteria |
| Details |
1. Women of reproductive age who are pregnant / lactating / not willing for adequate contraception
2. History of allergy to any medications including alternate system of medications
3. Inability to follow-the protocol or expressed inability to complete all follow-ups
4. History of allergic rhinitis, asthma, serious ailments of the heart. Liver or kidney, malignancies and any immunological disorders
5. History of any concomitant or chronic conditions involving the respiratory tract like bacterial pharyngitis, lower respiratory tract infections, Chronic obstructive pulmonary disease, interstitial lung disease, sinusitis etc.
6. Past history of Tuberculosis
7. User of any form of Tobacco everyday
8. Participants on medications / require any of the following medications – Antibiotics, Anti-viral agents, Anti-histaminics, Steroids, Decongestants, Herbal remedies, Vitamin C or Zinc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity symptom score assessed by WURSS-21 |
at baseline, 6 hours, days 2,3,5 & 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Score of symptoms (Cough , Expectoration , Nasal discharge , Headache , Fever Sore throat, Earache, Malaise/ Fatigue, Sleep disturbance ) From 0 to 100 : 0 being least and 100 being worst |
at baseline, 6 hours, and twice daily afterwards till day 7 |
| Adverse Event |
through out the study |
| C reactive protein, WBC, nasal mucociliary function test, IL-8 & IgA in nasal wash |
Baseline and day 3 |
| Nasal mucosal weight and tissue paper count |
Days 1, 2 and 3 |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2019 |
| Date of Study Completion (India) |
20/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript being written up for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Kalmegh (Andrographis
paniculata) is a native plant of India and Srilanka which has been widely
used as a natural remedy for common cold/ uncomplicated Upper Respiratory Tract
Infection (URTI). Its usefulness in
common cold has been shown by many studies and a meta-analysis of four RCTs
done (2004) showed that the difference in effect between A. paniculata and
placebo was 10.85 points (95% CI 10.36-11.34 points, P<0.0001) of the
symptom severity score in favour of A. paniculata. It is formulated as
Kalmcold / Ap-Bio.
In this clinical trial, we used objective measures and validated scales
to assess the efficacy of Kalmcold/AP-Bio, prepared from A. paniculata
against uncomplicated URTI. The study was approved by the institutional ethics
committee (EC/PHARMA-11/2019). We screened a total of n=331 participants and enrolled
n=300 participants. They were randomized in a 1:1:1 ratio to three groups
namely Kalmcold 200mg, Kalmcold 400mg and Placebo groups. The duration of all
interventions was for 7 days and the follow-up visits were done at day 3, day 5
and day 7. A telephonic follow-up was done at 6 hours and day 2. The primary efficacy measure studied was
(Wisconsin Upper Respiratory Tract Symptom score) WURSS-21. The study showed
that the intervention groups i.e., Kalmcold 200mg and 400mg groups showed
significantly better resolution of symptoms of uncomplicated URTI when compared
with placebo on Day 3. However, this difference is not maintained on day 5 and
day 7.
|