| CTRI Number |
CTRI/2024/03/064437 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of allergic runny nose |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in reducing symptoms of allergic rhino-conjunctivitis in adults: Double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-0936 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bidisha Ray |
| Designation |
Postgraduate Trainee |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Dept. of Materia Medica, OPD room no. PG2 and 7 (ENT), 12, Gobinda khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9163969154 |
| Fax |
|
| Email |
bidisharay66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saima Shamim |
| Designation |
Reader |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica; 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
7059526218 |
| Fax |
|
| Email |
drsaima_7@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saima Shamim |
| Designation |
Reader |
| Affiliation |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
Department of Materia Medica; 12, Gobinda Khatick Road, Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
7059526218 |
| Fax |
|
| Email |
drsaima_7@yahoo.com |
|
|
Source of Monetary or Material Support
|
| D. N. De Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
D. N. De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road, Tangra, Kolkata 700046, West Bengal |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Bidisha Ray |
D N De Homoeopathic Medical College and Hospital |
Department of ENT, Medicine and PG2 OPD, 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
9163969154
bidisharay66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D.N.De Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, (2) ICD-10 Condition: H104||Chronic conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical looking placebos plus concomitant care |
This group will receive placebo, identical in appearance with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of therapy: 3 months. Both medicines and placebos will be re-packed in identical glass bottles and labelled with code, name of medicine, potency, and will be dispensed according to the random number list. Concomitant care: All the enrolled patients will receive advice on diet and lifestyle modification during 3 months of therapy. Management for ARc include: (i) Steam inhalation can help soothe nasal passages. (ii) Allergen Avoidance (â…²)Saline nasal irrigation and use of humidifier. (â…³)Consuming local honey .This natural remedy can be particularly effective for individuals suffering from seasonal allergies, as it may help decrease the severity of symptoms. (â…´) Applying warm and cool compress for itchy eyes. (vi) Daily routine: Eating a balanced diet rich in fruits, vegetables, and whole grainsGetting regular exercise to boost overall health and immunity,Managing stress through relaxation techniques, such as meditation or yoga Ensuring adequate sleep to allow your body to recover (vii) Yoga Therapy: Hatha yoga, Nadishodhana and Ujjayi Pranayama and yoga postures like Virassna, Suptassna, Supta Baddhakonassna, Bhujangassna, Gomukhassna, Shavassna and Makarassna and kriya like jal Neti, Sutra Neti, Netra Sakhti vikasaka etc. |
| Intervention |
Individualized homoeopathic
medicines in centesimal
potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single individualized medicine will be prescribed on each occasion taking into account presenting symptom totality, clinical history details, constitutional features, miasmatic expressions, repertorization using HOMPATH/RADAR software when required with due consultation of Materia Medica and due consensus among three homoeopaths. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Provision will be kept to change the medicines or potencies and adjust the dosage in subsequent visits whenever required following the principles of classical homoeopathy and such instances will be compared between groups. Duration of therapy: 3 months. Concomitant care: All the enrolled patients will receive advices on diet and lifestyle modification during 3 months of therapy. Management for ARc include: (i) Steam inhalation can help soothe nasal passages. (ii) Allergen Avoidance (â…²)Saline nasal irrigation and use of humidifier. (â…³)Consuming local honey .This natural remedy can be particularly effective for individuals suffering from seasonal allergies, as it may help decrease the severity of symptoms. (â…´) Applying warm and cool compress for itchy eyes. (vi) Daily routine:
Eating a balanced diet rich in fruits, vegetables, and whole grainsGetting regular exercise to boost overall health and immunity,Managing stress through relaxation techniques, such as meditation or yoga
Ensuring adequate sleep to allow your body to recover
(vii) Yoga Therapy: Hatha yoga, Nadishodhana and Ujjayi Pranayama and yoga postures like Virassna, Suptassna, Supta Baddhakonassna,Bhujangassna, Gomukhassna, Shavassna and Makarassna and kriya like jal Neti, Sutra Neti, Netra Sakhti vikasaka etc.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from Allergic Rhino-conjunctivitis of mild to moderate intensity i.e. presenting the symptoms of Acute exacerbation of chronic Allergic-Rhino-conjunctivitis or Chronic Allergic Rhino-conjunctivitis (perennial and seasonal variety) [ICD 11 CA08.0Z] [ICD 11 9A60.02]
2.Age 18 to 65 years and of either sex or transgender.
3.History of recurrent attack of symptoms of Allergic Rhino-conjunctivitis since childhood
4.Atopic: reactive to inhaled allergens.
5.Elevated Absolute Eosinophil count and elevated Serum IgE level
6.Family history of atopy i.e. similar atopic conditions.
7.Participants having prior experience or knowledge of the treatment. Example- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet. |
|
| ExclusionCriteria |
| Details |
1.Nasal abnormalities causing obstruction; e.g. nasal polyps deviated septum.
2.Away from usual environment for more than 1 week during trial.
3.Respiratory infections
4.Patients with risk of developing bronchial asthma
5.Abnormalities of eyes causing severe or gross impairment of visual acuity
6.Patients having cataract or any other gross structural abnormalities of eyes
7.Patient having obstruction of Naso-lachrymal duct
8.Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
9.Patients who are too sick for consultation
10.Pregnant and puerperal women, and lactating mothers
11.Substance abuse and/or dependence
12.Self-reported immune-compromised state
13.Oral or parenteral steroids in past 6 months
14.Conventional desensitization in past 6 months
15.Not having any previous history of allergic attack of symptoms of Allergic rhino-conjunctivitis.
16.Previous homoeopathic immunotherapy for Allergic rhinitis or Allergic conjunctivitis within last 6 months.
17.Undergoing homoeopathic treatment for any chronic disease within last 6 months.
18.Uncontrolled hypertension, diabetes, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases or any other uncontrolled systemic diseases affecting quality of life or organ failure.
19.Simultaneous participation in any other trial.
20.Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally and critically ill patient, mentally incompatible patients.
21.Patient not providing written informed consent voluntarily. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mini-Rhino-conjunctivitis Quality of Life Questionnaire (Mini-RQLQ) |
Baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| RAND Medical Outcome Study Short Form Health Survey 36-symptom score 1.0 (RAND MOS SF 36 1.0) |
Baseline, every month, up to 3 months |
| Serum IgE |
Baseline, 3 months |
| Absolute eosinophil count |
Baseline, 3 months |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
01/04/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included bidisharay66@gmail.com).
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Allergic Rhino-conjunctivitis (ARc) is induced by IgE mediated immune
response after an allergen exposure characterized by presence of symptoms of
inflammation of nasal mucosa causing nasal congestion, rhinorrhoea, nasal
itching, watery and itchy eyes, sore eyes etc. This inflammation may also
involved the mucous membrane of middle, pharynx, conjunctiva, sinuses. There
are two varieties of ARc (a) Seasonal: symptoms around a particular season of
the year when the pollen count is high to which the patient is sensitive are
present in year and (b) Perennial: Symptoms present throughout the year. Most of the trial done by homoeopathic medicine prepared according to the Isopathic principle for treatment of ARc. Systematic Review of published trials showing high risk of bias in cochrane criteria. Some trials are going on but not yet published. All these show there is need to undertake a trial on ARc showing efficacy of individualized homoeopathic medicines in treatment of ARc.Thus
this double blind randomized (2:1), placebo controlled trial using individualized
homoeopathic medicine along with concomitant care will be conducted on 84
patients suffering from ARc in outpatient of D. N. De Homoeopathic Medical
College and Hospital. Primary outcome measure will be Mini-RQLQ at baseline,
every month and 3months of follow up. Secondary outcome measure will be (a)
RAND MOS SF 36 1.O symptom score at baseline, every month and 3 months of follow
up. (b) Serum IgE level and (c) Absolute Eosinophil count at baseline and end
of 3 months of follow up. Group differences will be analyzed statistically.
Results will be published in scientific journal.
|