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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  NA 
 
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.

 
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