| CTRI Number |
CTRI/2019/09/021351 [Registered on: 20/09/2019] Trial Registered Prospectively |
| Last Modified On: |
04/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Homeopathic formulation for Flu and Flu like symptoms. |
|
Scientific Title of Study
|
An open Label, non-randomised, clinical study to evaluate the efficacy of homeopathic formulation of Anacosinum pellets in patient with Flu and Flu like symptoms. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MCR/BHAR/AN/CT/006/9102 |
Protocol Number |
| MCR/BHAR/AN/CT/006/9102 Version: Original Protocol |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Sable |
| Designation |
Head of Clinical Operation |
| Affiliation |
Milagro Clinical Research |
| Address |
Office No A 615, Balaji Bhavan
Sector 11, CBD Belapur, Navi Mumbai.
Thane
MAHARASHTRA
400614
India |
| Phone |
917400407196 |
| Fax |
02227562224 |
| Email |
anjali@milagroclinicalresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trupti Desai |
| Designation |
Regulatory and Start Up Lead |
| Affiliation |
Milagro Clinical Research |
| Address |
Office No A 615, Balaji Bhavan
Sector 11, CBD Belapur, Navi Mumbai.
Thane
MAHARASHTRA
400614
India |
| Phone |
917400407193 |
| Fax |
02227562224 |
| Email |
trupti@milagroclinicalresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Trupti Desai |
| Designation |
Regulatory and Start Up Lead |
| Affiliation |
Milagro Clinical Research |
| Address |
Office No A 615, Balaji Bhavan
Sector 11, CBD Belapur, Navi Mumbai.
Thane
MAHARASHTRA
400614
India |
| Phone |
917400407193 |
| Fax |
02227562224 |
| Email |
trupti@milagroclinicalresearch.com |
|
|
Source of Monetary or Material Support
|
| Bhargava Phytolab Limited E 1216 Ghatal Bhiwadi industrial area, Bhawadi, Rajastan India 301019 |
|
|
Primary Sponsor
|
| Name |
Bhargava Phytolab Limited |
| Address |
E 1216, Ghatal, Bhiwadi Industrial Area, Bhiwadi, Rajastan, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Milagro Clinical Research |
Milagro Clinical Research Office no A-615, Balaji Bhavan, Sector-11, CBD Belapur- 400614. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish Kulkarni |
Dr Girish K Kulkarni Clinic |
Sector 8, Plot No 10, Phase Ii, Trupti Shopping Centre, Nerul (W), Jai Bhavani Marg, Navi Mumbai, Maharashtra. 400706.
Thane
MAHARASHTRA |
917400407195
02227562224
drgirishkkulkarni@gmail.com |
| Dr Bhushan Badgujar |
SANJIVANI CLINIC |
Shop No. 1, Neera Niwas,Gaon Devi Road, Sec. 36, Karave Gaon, Nerul (W.), Navi Mumbai – 400 706. Maharashtra, India.
Thane
MAHARASHTRA |
917400407195
02227562224
drbhushan2001@gmail.com |
| Dr Dilip Munde |
Siddhivinayak Clinic |
Siddhivinayak Clinic, F5/02, Sector-7, Simplex, Ghansoli, Navi Mumbai.
Thane
MAHARASHTRA |
917400407195
02227562224
dilipmunde0709@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Vision Independent Ethics Committee |
Approved |
| Vision Independent Ethics Committee |
Approved |
| Vision Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J101||Influenza due to other identifiedinfluenza virus with other respiratory manifestations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anacosinum Pellets |
All eligible subjects who meet the Inclusion and Exclusion will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit) and Day 7.
200 subjects will be enrolled.
Subjects in study will receive active Investigational product and advised to take 1 vial thrice a day before food
Physical examination and Demographics will be recorded at screening time.
Physical examination and monitoring will be continuing on baseline and Day7.
Vitals will be recorded on all visits.
Temperature will be recorded daily upto 7 days.
Visual Analog Scale (VAS) Score on baseline and day 7
(Intensity of pain will be graded from 0-9. Pain intensity will be assessed in each case)
Adverse events will be monitored up to 7 days and will be recorded on day 1 and day 7. A buffer period of ±1 day will be allowed for visit and beyond which it will be considered as a protocol deviation.
All the subjects who meet the eligibility criteria and have received at least one dose of study medication and had post baseline efficacy data will be included in the efficacy analysis
All subjects who shall receive at least one dose of study
drug will be included in the safety analysis
Patient data from all the centers will be pooled
together and analyzed using paired t- test.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The Inclusion criteria are as follows (“Yes†to all the following will allow the subjects to be included into study)
1 Age: Adult-Above 18 years to below 60 years, both male and female
2 Willing to sign written inform consent
3 Patients recently diagnosed with Flu, the following signs and symptoms
Diagnosis of Mild to Moderate Headache, Body ache and other symptoms of cough cold.
Sore throat.
Sneezing/ Nasal irritation.
Headache.
Cough.
Runny nose.
Malaise.
With or without low grade fever (<102 F)
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria are as follows (“Yes†to any one of the following will allow PI to exclude the subject from enrolling into the study
1 Upper Respiratory Tract Infections (URI or URTI) including rhinitis, sinusitis, pharyngitis, tonsillitis, laryngitis, tracheitis and otitis media.
2 Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia and acute bronchitis.
3 Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema
4 Bronchial Asthma
5 H/o Pulmonary Tuberculosis
6 Tumours of larynx, bronchi, and lungs
7 Drug-induced Cough (e.g., ACE Inhibitors)
8 Diabetes Mellitus, Hypertension
9 Known cases of severe hepatic, renal or cardiac ailments
10 H/o addiction (smoking, alcohol, drugs)
11 K/h/o hypersensitivity to herbal extracts or dietary supplements
12 Pregnant women, lactating women and women of child-bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic relief from clinical symptoms of Flu and Flu like symptoms |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety profile of Anacosinum pellets in Flu and overall compliance to the drug treatment. |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2019 |
| Date of Study Completion (India) |
04/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/10/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
All
eligible subjects who meet the Inclusion and Exclusion will be enrolled into
the study will have to visit the study site on screening, Day 0 (Baseline
visit) and Day 7.
200
subjects will be enrolled.
Subjects
in study will receive active Investigational product and advised to take 1 vial
thrice a day before food
Physical
examination and Demographics will be recorded at screening time.
Physical
examination and monitoring will be continuing on baseline and Day7.
Vitals
will be recorded on all visits.
Temperature will be recorded daily upto 7 days.
Visual
Analog Scale (VAS) Score on baseline and day 7
(Intensity
of pain will be graded from 0-9. Pain intensity will be assessed in each case).
Adverse
events will be monitored up to 7 days and will be recorded on day 1 and day 7.
A buffer period of ±1 day will be allowed for visit and beyond which it will be
considered as a protocol deviation.
All the subjects who meet the eligibility
criteria and have received at least one dose of study medication and had post
baseline efficacy data will be included in the efficacy analysis
All subjects who shall receive at least one dose
of study
drug will be included in the safety analysis
Patient data from all the centers will be pooled
together and analyzed using paired t- test.
|