CTRI Number |
CTRI/2020/05/025141 [Registered on: 13/05/2020] Trial Registered Prospectively |
Last Modified On: |
15/03/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
Effectiveness of Homoeopathic medicines in Allergic Common Cold |
Scientific Title of Study
|
Single blind Comparative Experimental study in the modulation of ‘Serum Immunoglobulin-E’ levels of ‘Allergic Rhinitis’ patients treated with Specific Homoeopathic Medicines - Galphimia glauca.6C, Luffa operculata.6C & Penthorum Sedoides.6C |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr H Venkatesan |
Designation |
Research Coordinator & Associate Professor |
Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
Room No 5, Dept of Research & Development, First Floor, PG Block,
Vinayaka Missions Homoeopathic Medical College and Hospital, NH
47, Sankari Main Road, Seeragapadi PO, Salem
Salem TAMIL NADU 636308 India |
Phone |
9865134561 |
Fax |
|
Email |
venkathompath@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr H Venkatesan |
Designation |
Research Coordinator & Associate Professor |
Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
Room No 5, Dept of Research & Development, First Floor, PG Block,
Vinayaka Missions Homoeopathic Medical College and Hospital, NH
47, Sankari Main Road, Seeragapadi PO, Salem
TAMIL NADU 636308 India |
Phone |
9865134561 |
Fax |
|
Email |
venkathompath@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr H Venkatesan |
Designation |
Research Coordinator & Associate Professor |
Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Address |
Room No 5, Dept of Research & Development, First Floor, PG Block,
Vinayaka Missions Homoeopathic Medical College and Hospital, NH
47, Sankari Main Road, Seeragapadi PO, Salem
TAMIL NADU 636308 India |
Phone |
9865134561 |
Fax |
|
Email |
venkathompath@gmail.com |
|
Source of Monetary or Material Support
|
Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari
Main Road, Seeragapadi PO, Salem, Tamilnadu, Pincode 636308 |
|
Primary Sponsor
|
Name |
Vinayaka Missions Research Foundation Deemed to be University |
Address |
NH 47, Sankari Main road, Ariyanoor, Salem - 636 308 |
Type of Sponsor |
Other [Affiliating University ] |
|
Details of Secondary Sponsor
|
|
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,NH 47, Sankari
Main Road,
Seeragapadi PO,
Salem, Tamilnadu - 636 308 Salem TAMIL NADU |
9865134561
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: J305||Allergic rhinitis due to food, (2) ICD-10 Condition: J301||Allergic rhinitis due to pollen, (3) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (4) ICD-10 Condition: J308||Other allergic rhinitis, (5) ICD-10 Condition: J302||Other seasonal allergic rhinitis, (6) ICD-10 Condition: J300||Vasomotor rhinitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Galphimia glauca.6C |
Dose: 5 Medicated Globules of 30 Size.
Frequency: Morning & night every day before food.
Route of Administration: Oral.
Duration of Administration: 90 Days. |
Intervention |
Luffa operculata.6C |
Dose: 5 Medicated Globules of 30 Size.
Frequency: Morning & night every day before food.
Route of Administration: Oral.
Duration of Administration: 90 Days. |
Comparator Agent |
Not Applicable |
Not Applicable |
Intervention |
Penthorum Sedoides.6C |
Dose: 5 Medicated Globules of 30 Size.
Frequency: Morning & night every day before food.
Route of Administration: Oral.
Duration of Administration: 90 Days. |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Clinically Diagnosed patients of Allergic Rhinitis patients with Serum Immunoglobulin - E Level ≥ 158 IU/mL or as per the reference range in other Units / for other laboratory methods |
|
ExclusionCriteria |
Details |
Allergic Rhinitis with Systemic infection or Complications.
Patients with Occupational Health Hazards or Repeated Exposure.
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Symptomatic Relief of Allergic Rhinitis Symptoms.
Reduction in Serum IgE Levels. |
90 Days |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/06/2020 |
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="0" Months="8" 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)?
Response - NO
|
Brief Summary
|
Allergic rhinitis is an
inflammatory disorder of the nasal mucosa induced by allergen exposure
triggering IgE-mediated inflammation. Clinically, it is characterized by four
major symptoms–rhinorrhea, sneezing, nasal itching, and nasal congestion. It
can also be associated with co-morbid conditions as Asthma, Atopic Dermatitis
& Nasal polyps. Around 20–30 % of the Indian population suffers from
allergic rhinitis and that 15 % develop asthma. Allergic Rhinitis symptoms
result in sleep disturbance, fatigue, depressed mood and cognitive function
compromise that impairs quality of life and productivity.
A number of
pharmacologic interventions are prescribed to treat Allergic Rhinitis.
Intranasal corticosteroids (INC) are recommended in current guidelines as
first-line therapy for patients with moderate to severe Allergic Rhinitis,
particularly when nasal congestion is the prominent symptom.
Preservatives in the
INC formulation may produce nasal irritation and may impart unacceptable taste or odour to the
formulation. Further, the relative osmotic pressure or tonicity of the
formulation can modulate nasal retention and absorption, thereby potentially
influencing clinical efficacy.1 The use of INC may tend to cause
adverse effects like a stinging or burning sensation in the nose, dryness and
crustiness in the nose, a dry, irritated throat, an unpleasant taste
in the mouth, itchiness, redness and swelling in the nose, nosebleeds,
etc., Furthermore INC could relieve the Nasal Congestion only that
too for a limited time period. They don’t play a role in modulating the
immunity of the patient, Prevention or Cure of the Allergic Rhinitis.
The Diagnosis of Allergic Rhinitis is based on
Typical history of allergic symptoms ‘‘sneezers and runners’’. All patients
with persistent allergic rhinitis need a nasal examination (Anterior
rhinoscopy, Nasal endoscopy). The diagnostic tests are directed towards the
detection of free or cell bound IgE. Immediate hypersensitivity skin tests are
widely used to demonstrate an IgE-mediated allergic reaction. These represent a
major diagnostic tool in the field of allergy. The measurement of
allergen-specific IgE (radioallergosorbent testing, RAST) in serum is of
importance and is of similar value to skin tests. They are more useful in
patients having dermatitis, dermographism, and in cases where antihistamines
have to be continued during testing.
Various Clinical Trials
conducted by ‘CCRH, New Delhi’ and other reputed institutions across globe have
demonstrated the efficacy of Homoeopathic management of Allergic Rhinitis.
Homoeopathic Medicines like Allium cepa, Sabadilla, Aurum triphyllum,
Euphrasia, Hepar sulphuris, Arsenicum iodatum, Kalium iodatum, etc., are found
to be effective in treating Allergic Rhinitis by Previous Studies.
Lesser known drugs like
Galphimia glauca.6C, Luffa operculata.6C &
Penthorum Sedoides.6C are also found to be
clinically effective in treating Allergic Rhinitis by literature survey. But
their effect on modulation of Elevated Serum Immunoglobulin-E levels in
Allergic Rhinitis patients is not yet explored by any of the Researches across
the World.
These details intended
me to do a comparative experimental study on the effectiveness of the three said
medicines in the modulation of Serum Immunoglobulin-E levels in Allergic
Rhinitis patients. |