| CTRI Number |
CTRI/2012/01/002320 [Registered on: 03/01/2012] Trial Registered Prospectively |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To see effetiveness of homoeopathic medicines on chronic rhinosinusitis against placebo |
|
Scientific Title of Study
|
A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED MULITCENTRIC TRIAL ON THE EFFECTS OF HOMOEOPATHIC MEDICINES ON CHRONIC RHINOSINUSITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alok Kumar |
| Designation |
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 India
South West
DELHI
110058
India |
| Phone |
01128525523 |
| Fax |
01128521060 |
| Email |
ccrhindia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Assistant Director (H) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61- 65, Institutional Area Opp. D -Block Janakpuri New Delhi India
South West
DELHI
110058
India |
| Phone |
09811952274 |
| Fax |
01128521060 |
| Email |
oberai.praveen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Oberai |
| Designation |
Assistant Director (H) |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61- 65, Institutional Area Opp. D -Block Janakpuri New Delhi India
South West
DELHI
110058
India |
| Phone |
09811952274 |
| Fax |
01128521060 |
| Email |
oberai.praveen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61- 65, Institutional Area Opp. D -Block Janakpuri New Delhi India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhash Kaushik |
Central Research Institute (H) |
A-1/1. Sector-24,
Noida.(U.P.).
Gautam Buddha Nagar
UTTAR PRADESH |
09810788976
dr_subhash10@hotmail.com |
| Dr M N Sinha |
Regional Research Institute (H) |
Dr. Madan Pratgap Khuteta Rajasthan Homoeopathic Medical College & Hospital,
Station Road, Jaipur (Rajasthan)
Jaipur
RAJASTHAN |
09460500979
rrihjaipur@gmail.com |
| Dr Sarabjit Sarkar |
Regional Research Institute (H) |
Regional Research Inst. (H),
Rabha Bhawan,
Odalbakra, Kahilipara,
Guwahati-7810034.
Kamrup
ASSAM |
09435546903
rrihgua@gmail.com |
| Dr Sunil Ramteke |
Regional Research Institute (H) |
Regional Research Inst. (H),
House No.2, Type-D, Lane-1,
Sector-1, Below B.C.S.,
New Shimla, (H.P.)-171009.
Shimla
HIMACHAL PRADESH |
09416211118
rrihshimla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CCRH Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic rhinosinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines
Acid Nit.
Aconitinum
Allium Cepa
Antimodicum Crude
Apis Mel
Arsenicum Alb
Arsenicum Iod
Aurum Metallicum
Belladonna
Berbaris Vulgaris
Byronia Alb
Calcarea Carbonica
Calcarea Hypophosphorosa
Carbo Veg.
Causticum
Colocynthis
Dulcamara
Gelsemium
Graphites
Hepar Sulphur
Ignatia
Ipecacuanha
Justicia Adhatoda
Kalium Ars.
Kalium Bich.
Kalium Carb
Kalium Iod
Kalmia Lat
Kreosote
Lobelia
Lilium Tigrinum
Lycopodium
Magnesia Carbonica
Magnesium Phos
Mercurius Iodatus Ruber
Mercurius Sol.
Natrum Carbonicum
Natrum Mur
Natrum Phos
Natrum Sulph
Nux Vomica
Phosphorus
Psorinum
Pulsatilla
Pyrogenium
Rhus Tox.
Sanguinaria Canadensis
Sepia
Silicea
Spigelia Anthelmia
Spongia Tosta
Stannum Metallicum
Staphysagria
Sulphur
Thuja Occ.
Tuberculinum
|
the indicated trial medicine shall be given to patient as per homoeoapthic principles, 15 ml once daily or as per need for 3 months |
| Comparator Agent |
Placebo |
the identical placebo will be given in similar to the indicated medicine, 15 ml once daily or as per need for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18-60 years from both gender.
2.Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e.
-Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip):
- facial pain/pressure
- reduction or loss of smell
for >12 weeks with validation by interview.
3 Written informed consent
4 Patients who can act in accordance with the protocol
|
|
| ExclusionCriteria |
| Details |
1Patients who are not adequately symptomatic.
2Patients with serious underlying medical condition (eg. Severe renal or hepatic disease)
3Patients with history of malignancy.
4Patients taken any medication prior to entry into the study (can be enrolled after wash out period of 15 days).
5Patients taken topical steroids within 4 weeks before the study therapy (can be enrolled after wash out period of 1 month)
6 Atrophic rhinitis
7Complications of chronic rhinosinusitis
8Significant psychological problems
9Pregnant women
10 Lactating mother
11Do not give informed consent.
12H/o of underlying immunodeficiencies, cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease, diabetes mellitus, neoplasia or fungal sinusitis.
13Systemic diseases preventing participation in the study and medical and/or surgical treatments influencing the study.
14 No prior paranasal sinus, nose surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To assess the improvement in the TSS over 3 months with area under the curve.
• The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22)
|
•To assess the improvement in the TSS over 3 months with area under the curve.
• The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Change in SNOT-22 at 6 months
•Objective clinical and laboratory outcome measures include changes in nasal endoscopy (at 3 months, 6 months) and CT scan (at 3 months).
•Changes in absolute eosinophilic count (AEC) at 3 months.
•No. of AE-CRS during observation period which includes endoscopic findings. Number of AE-CRS (FDI) in between groups.
•Changes in global assessment by patient and physician at 3 months and 6 months.
|
3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2012 |
| 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="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomized Double Blind Placebo Controlled Mulitcentric Trial on the effects of Homoeopathic Medicines on Chronic Rhinosinusitis shall be conducted by Central Council for Research in Homoeopathy at its four institutes for a duration of 18 months (6 months for enrollment + 3 months treatment+ 3 months observation period+ 6 months for data analysis and manuscript preparation) with primary objective to evaluate the changes in total symptoms score (TSS) and the changes in Sino nasal outcome test -22 (SNOT-22). A total of 120 patients shall be enrolled (30 for each centre in the ratio Homoeoapthy:Placebo:20:10). The main Inclusion Criteria are Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e. Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip), facial pain/pressure, reduction or loss of smell for >12 weeks with validation by interview, Written informed consent, Patients who can act in accordance with the protocol, evidence of rhinosinusitis on imaging by CT Scan. One group will be given individualized homoeopathic medicines and the other group will be given placebo orally. For a period of 3 months.TSS score, Sino Nasal Outcome Test-22, Lund Mackay CT scoring, Nasal Endoscopy scoring, Absolute Eosinophil Count (AEC) will be used for assessement. |