| CTRI Number |
CTRI/2019/09/021405 [Registered on: 25/09/2019] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Homoeopathic Medicines Azadirachta indica-Q and Echinacea angustifolia-Q in Allergy |
|
Scientific Title of Study
|
Single Blind Randomized Comparative Study in the Modulation of Serum Immunoglobulin-E levels of Atopic patients treated with Azadirachta indica-Q and Echinacea angustifolia-Q |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandhagopal S |
| Designation |
BHMS |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Vinayaka Missions Homoeopathic Medical College and Hospital,
NH47, Sankari main Road, Seeragapadi PO, Salem
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9445058974 |
| Fax |
|
| Email |
gopalnandhu1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Venkatesan |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Vinayaka Missions Homoeopathic
Medical College and Hospital, NH47, Sankari main Road,
Seeragapadi PO, Salem
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Venkatesan |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Vinayaka Missions Homoeopathic
Medical College and Hospital, NH47, Sankari main Road,
Seeragapadi PO, Salem
Salem
TAMIL NADU
636308
India
Salem
TAMIL NADU
636308
India |
| Phone |
09865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari main Road,
Seeragapadi PO, Salem, Tamilnadu - 636308 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area, Opp D Block, Janak Puri, New Delhi
110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vinayaka Missions Homoeopathic Medical College and Hospital |
NH47, Sankari main Road, Seeragapadi PO,
Salem, Tamilnadu - 636308 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H Venkatesan |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No : 5 B - Dept of
Practice of Medicine,
Vinayaka Missions
Homoeopathic Medical
College and Hospital,
NH47, Sankari main
Road, Seeragapadi PO,
Salem, Tamilnadu -
636308
Salem
TAMIL NADU
Salem
TAMIL NADU |
986513456
venkathompath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R768||Other specified abnormal immunological findings in serum, (2) ICD-10 Condition: D824||Hyperimmunoglobulin E [IgE] syndrome, (3) ICD-10 Condition: L20||Atopic dermatitis, (4) ICD-10 Condition: J45||Asthma, (5) ICD-10 Condition: J30||Vasomotor and allergic rhinitis, (6) ICD-10 Condition: B65-B83||Helminthiases, (7) ICD-10 Condition: L500||Allergic urticaria, (8) ICD-10 Condition: Z910||Allergy status, other than to drugs and biological substances, (9) ICD-10 Condition: T784||Other and unspecified allergy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Azadirachta indica-Q |
20 Drops in 10 ml of water per oral route morning and night every day half an hour before food for 90 days |
| Comparator Agent |
Echinacea angustifolia-Q |
20 Drops in 10 ml of water per oral route morning and night every day half an hour before food for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with elevated Serum Immunoglobulin-E (IgE) level with or without any Clinical Manifestation.
2. Elevated IgE level > 158 IU/mL or as per the reference range in other Units / for other laboratory methods.
3. Patients associated with Atopic Symptoms.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Systemic Complications
2. Patients with Autoimmune diseases.
3. Those who are already under chronic medication for elevated IgE levels.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Serum Ig-E Levels |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic Relief |
90 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2019 |
| Date of Study Completion (India) |
30/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The classic Definition of Immunity
is protection from Infectious pathogen & the normal immune response. An important undesirable side effect of immunity is the development,
under some conditions, of allergy or other types of Immune Hypersensitivity.
Hypersensitivity is defined as an exaggerated or
inappropriate state of normal immune response with onset of adverse effects on
the body. For the induction of Hypersensitive reactions, the host
should have had contact with the antigen (allergen). During first contact of
host with antigen, sensitisation takes place. Subsequent contact with allergen
causes manifestation of Type-1 Hypersensitivity.
Antibodies (Cytotropic IgE) are fixed on surface of
tissue cells in sensitized individuals. These combines with cell fixed
antibody, leading to release of pharmacologically active substances which
produce the clinical reaction.
‘Atopy’ is defined as a personal and/or familial tendency,
to become sensitized and produce IgE antibodies in response to ordinary
exposure to allergens, usually proteins. Therefore Atopy is an IgE antibody
high-responder who may or may not have clinical symptoms. Symptoms
of Type-I hyperÂsensitivity that begin after a clearly defined environmenÂtal
exposure should prompt to eliminate future exposure
to the suspected allergen.
The heart of the allergic response lies in the
quantity and specificity of IgE production of patients to allergens. The
history, aided by a physical examination and objecÂtive tests of IgE
sensitivity (either skin tests or serum IgE measurements), is often used to
diagnose Allergic / Atopic conditions.
Azadirachta indica (Neem) and
Echinacea angustifolia (Narrow-leaf coneflower) are found to
be effective as immune modulators both in Animal and Human Studies conducted
earlier. They are also found to be effective in treating Atopic patients in
Homoeopathy too.
These details intended me to do the comparative
study of the effectiveness of the two said medicines in controlling serum Ig-E
levels of atopic patients. |