| CTRI Number |
CTRI/2012/04/002590 [Registered on: 20/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
30/03/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Scope of homoeopathic medicine in influenza |
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic Treatment In Influenza Like Illness- A multicentric, Single Blind, Randomized, Placebo Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrCNayak |
| Designation |
former Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janakpuri
New Delhi-110058
South West
DELHI
110058
India |
| Phone |
09958495858 |
| Fax |
|
| Email |
drcbnayak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPS Chakrabarty |
| Designation |
Assistant Director (H) |
| Affiliation |
CCRH |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janakpuri
New Delhi-110058
South West
DELHI
110058
India |
| Phone |
09015618609 |
| Fax |
|
| Email |
drpsch@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrPS Chakrabarty |
| Designation |
Assistant Director (H) |
| Affiliation |
CCRH |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janakpuri
New Delhi-110058
DELHI
110058
India |
| Phone |
09015618609 |
| Fax |
|
| Email |
drpsch@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| central council for Research in Homoeopathy, Department of AYUSH, New Delhi. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy New Delhi |
| Address |
Central Council for Research in Homoeopathy
61-65, Institutional Area, Opp. D-Block, Janakpuri
New Delhi-110058
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrKumar vivekanand |
Central Research Institute(H), A-1/1. Sector-24, |
Central Research Institute(H),
A-1/1. Sector-24,
Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
0120-2411320
crihnoida@gmail.com |
| DrMDJhon |
Clinical Research Unit (H), |
Clinical Research Unit (H),
M.B. 31, Middle Point,
Mahatma Gandhi Road,
Port-Blair (A&N) - 744101.
Andamans
ANDAMAN & NICOBAR ISLANDS |
03192-233073
cruhportblair@yahoo.com |
| DrKRaju |
Clinical Research Unit(H), |
Clinical Research Unit(H),
No.103/4, Kalakshetra Colony, 30thj Cross Street, (Opp. RBI Staff Qr.), Chennai - 600090. Tamil Nadu
Chennai
TAMIL NADU |
044-24511821
cruaids@yahoo.com |
| Dr Amitabh Poddar |
Clinical Research Unit(T) for Homoeopathy, |
Clinical Research Unit(T)
for Homoeopathy,
Netaji Subhash Road, Subhashpally, Siliguri
(W.B.)- 734401.
Darjiling
WEST BENGAL |
0353-2596065
cruslg@gmail.com |
| Dr H Baig |
Drug Standardisation Unit(H), |
Drug Standardisation Unit(H),
Q.U.B. 32, Room No. 4,
Vikram Puri, Habsiguda, Hyderabad (A.P.)
-500007.
(Andhra Pradesh)
Hyderabad
ANDHRA PRADESH |
040-27178188
drhafeezullahbaig@gmail.com |
| DrAKPrushty |
Regional Research Inst. (H), |
Regional Research Inst. (H),
CCRH Building, Marchi Kote Lane,Labanikhia Chaak,
Puri (Orissa)-752001.
Puri
ORISSA |
06752-225571
rri_puri@yahoo.co.in |
| DrVinod Kumar Singh |
Regional Research Inst. (H), Opp. Palace Compound |
Regional Research Inst. (H), Opp. Palace Compound, Indoor Stadium, Near Shri Govinda Jee Temple,
Imphal (Manipur)-795001
Imphal East
MANIPUR |
0385-2457417
rrihimphal@gmail.com |
| DRJSArya |
Regional Research Institute (H), Rabha Bhawan, Khalipara, Odel Bakara, Guwahati (Assam)-7810034 |
Regional Research Institute (H), Rabha Bhawan, Khalipara, Odel Bakara, Guwahati (Assam)-7810034
Kamrup
ASSAM |
0361-2476202
rrigua@yahoo.com |
| DRDBSarkar |
Regional Research Institute for Homoeopathy |
Regional Research Institute for Homoeopathy,
50, Rajendra Chatterjee Road, Kolkata – 35 West Bengal
Kolkata
WEST BENGAL |
033-28400507
dpru_kolkata@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Influenza like illness., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines selected on basis of Individualization |
Indicated Medicine was prescribed in LM potency or CM potency to patients in verum group after randomisation. The medicines were to be taken orally.The treatment was provided for a day to a maximum of 10 days depending upon the intensity of the disease and response to the first prescription following the principles of homoeopathy. |
| Comparator Agent |
Placebo |
Given to placebo group after randomization in identical form as verum group. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients meet all of the following criteria shall be eligible for study participation:
Patients of either sex, age group 12-60 years, presenting to study physician within 36hrs of onset of symptoms.
Patients presenting with signs/symptoms of influenza like illnesses: Abrupt onset of fever (≥100.4°F or 38oC body temp.) with at least one respiratory symptom ï›cough, sore throat, or nasal symptom (discharge, obstruction)ï and at least one constitutional symptom (headache, malaise, myalgia, sweats or chills, or fatigue).
|
|
| ExclusionCriteria |
| Details |
Patients meeting any of the following criteria shall be excluded:
• Who have received other medication (anti-viral) within the 36 hours before entry into the study.
• Patients who had immunization against influenza or influenza like illnessess for that season.
• Inability to comply with the study protocol, including psychiatric diseases.
• Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction.
• Pregnant women.
• Lactating mother.
• History of drug or alcohol abuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate effect of Homoeopathic medicines in the treatment of influenza like illness. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To caopare the complication rate among patients receiving homoeopathic medication as compare to the complication rate in patients receiving placebo.
To compare the efficacy of LM potency vis-a-vis Centesimal potency |
2 years |
|
|
Target Sample Size
|
Total Sample Size="432"
Sample Size from India="432"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/06/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Data under compilation. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A multicentric randomized, placebo controlled study on effect of individualized homoeopathic treatment on Influenza like illness shall be carried out by Central Council for Research in Homeopathy at its various Institutes/ Units throughout India. Participants shall be selected from both sexes, age ranging between 12-60 years presenting with signs and symptoms of Influenza like illness. Visual analog scale (VAS) ranging from 0-10 shall be used for assessing headache, myalgia, malaise, throat pain, nasal complaints, chill and sweat. Cough shall be measured with scale developed by Hsu et al. The data generated shall be assessed using SPSS statistical package, version 16 and the results shall be disseminated to the medical fraternity. |