Rhinitis; Allergic, With AsthmaSBRCTHILARBANCT02255136
Efficacy Study of Homeopathic Medicines in Treatment of Allergic Rhinitis and/or Induced Bronchial Asthma
A study testing Individualized homeopathic medicines in people with Rhinitis; Allergic, With Asthma, run by Mahesh Bhattacharyya Homoeopathic Medical College and Hospital at 1 site in India.
Trial summary
The purpose of this study is to test whether individualized homeopathic medicines can produce any significant effect beyond placebo in treatment of allergic rhinitis and/or induced bronchial asthma Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Rhinitis; Allergic, With Asthma
- What is being tested?
- Individualized homeopathic medicines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 5 and 65 years
- Both sexes
- Atopic: reactive to allergens with positive skin prick test (SPT) results and/or eosinophilia
- More than 1 year history of allergic rhinitis and/or induced bronchial asthma
Who cannot join
- Nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc.
- Previous homoeopathic immunotherapy for allergic rhinitis
- Allergen avoidance in past 6 weeks
- Away from usual environment for more than 1 week during trial
- Severe asthma cases as detected clinically
- Respiratory infection
Show all 10Show fewer
- Severe concomitant disease
- Pregnancy, breast feeding, or likelihood of pregnancy
- Oral or parenteral steroids and/or decongestant in past 6 months
- Conventional desensitization in past 3 months
Trial locations and contacts
1 site in 1 country.
India1 site
Mahesh Bhattacharyya Homeopathic Medical College & Hospital
Howrah, West Bengal, 711104
About this study
Official title: An Evidence-based Single-blind Randomized Controlled Trial Searching for the Efficacy of Homoeopathic Medicines in Reducing Serum Levels of Cytokines (IL - 10, 13) and Immunoglobulin E in Allergic Rhinitis and/or Induced Bronchial Asthma
The purpose of this study is to test whether individualized homeopathic medicines can produce any significant effect beyond placebo in treatment of allergic rhinitis and/or induced bronchial asthma
Read the detailed description
A prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial is being conducted on 100 participants (subjects 50, control 50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal. This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1 year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for independent and consequent variables will be done to test for bias. Parametric or non-parametric tests will be employed as per distribution of data at the end of the trial.
- Conditions
- Rhinitis; Allergic, With Asthma
- Being tested
- Individualized homeopathic medicines, Placebo
- Keywords
- Interleukin, Immunoglobulin, Homeopathy, Allergic Rhinitis, Asthma
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized homeopathic medicinesOther
5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year
PlaceboOther
Also called Placebo: distilled water
Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water
| Study group | Role | What they receive |
|---|---|---|
| Individualized homeopathic medicines | Experimental | Psorinum, Tuberculinum, Medorrhinum, Calcarea carbonica, Natrum sulphuricum etc. as indicated; Rescue medicines, e.g. Aralea racemosa, Arsenicum album, Histamine hydrochloride, House dust, Ipecacuanha, Antimonium tartaricum, Grindelia robusta etc. as indicated; 5 ml dose of indicated homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; administered twice daily for 1 year Receives: Other: Individualized homeopathic medicines |
| Intervention placebo | Placebo comparator | 5 ml dose made up of single drop of rectified spirit in 5 ml distilled water, identical in appearance of homeopathic medicine, to be administered twice daily for 1 year Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Interleukin 10 and 13 level
Measured: 1 year
Secondary outcomes (1)
Incidence of adverse events if any
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startMar 2012
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis; Allergic, With AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Shubhamoy Ghosh, MD (Hom), Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
- Investigators
- Shubhamoy Ghosh, MD(Hom), Principal investigator, Lecturer of the Department of Pathology & Microbiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255136
- Sponsor's protocol ID
- 793/MBHMCH/CH/Adm/01/2011
- Other IDs
- CTRI/2012/02/002419
- Acronym
- SBRCTHILARBA
- Status last verified
- Aug 2018
- First submitted
- 15 Feb 2012
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evidence-based Single-blind Randomized Controlled Trial Searching for the Efficacy of Homoeopathic Medicines in Reducing Serum Levels of Cytokines (IL - 10, 13) and Immunoglobulin E in Allergic Rhinitis and/or Induced Bronchial Asthma
- ClinicalTrials.gov ID
- NCT02255136
- Acronym / sponsor ID
- SBRCTHILARBA / 793/MBHMCH/CH/Adm/01/2011
- Conditions
- Rhinitis; Allergic, With Asthma
- Keywords
- Interleukin, Immunoglobulin, Homeopathy, Allergic Rhinitis, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mahesh Bhattacharyya Homoeopathic Medical College and HospitalOther government
- Study start
- Mar 2012 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether individualized homeopathic medicines can produce any significant effect beyond placebo in treatment of allergic rhinitis and/or induced bronchial asthma
Detailed description
A prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial is being conducted on 100 participants (subjects 50, control 50) suffering from allergic rhinitis and/or induced bronchial asthma since March 1, 2012 at Mahesh Bhattacharyya Homeopathic Medical College and Hospital, Government of West Bengal. This trial is aimed at exploring the efficacy of homeopathic medicines in comparison with placebo in reducing serum interleukin 10, 13 and immunoglobulin E measured at timeline of 1 year of treatment and absolute eosinophil count every 4 months up to 1 year. Matching for independent and consequent variables will be done to test for bias. Parametric or non-parametric tests will be employed as per distribution of data at the end of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, single-blind (subject), randomized, placebo-controlled, parallel group, interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Individualized homeopathic medicines | Experimental | Other: Individualized homeopathic medicinesPsorinum, Tuberculinum, Medorrhinum, Calcarea carbonica, Natrum sulphuricum etc. as indicated; Rescue medicines, e.g. Aralea racemosa, Arsenicum album, Histamine hydrochloride, House dust, Ipecacuanha, Antimonium tartaricum, Grindelia robusta etc. as indicated; 5 ml dose of indicated homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; administered twice daily for 1 year |
| Intervention placebo | Placebo comparator | Other: Placebo5 ml dose made up of single drop of rectified spirit in 5 ml distilled water, identical in appearance of homeopathic medicine, to be administered twice daily for 1 year |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 5 and 65 years
- Both sexes
- Atopic: reactive to allergens with positive skin prick test (SPT) results and/or eosinophilia
- More than 1 year history of allergic rhinitis and/or induced bronchial asthma
Key exclusion criteria (10 listed)
- Nasal abnormalities causing obstruction, e.g. nasal polyp(s), deviated septum etc.
- Previous homoeopathic immunotherapy for allergic rhinitis
- Allergen avoidance in past 6 weeks
- Away from usual environment for more than 1 week during trial
- Severe asthma cases as detected clinically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized homeopathic medicines5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year | Other | Individualized homeopathic medicines |
| PlaceboAlso: Placebo: distilled waterPlacebo, in the form of a single drop of rectified spirit in 5 ml of distilled water | Other | Intervention placebo |
Primary outcome
Serum Interleukin 10 and 13 level
Time frame: 1 year
1 secondary outcome
Incidence of adverse events if any
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubhamoy Ghosh, MD(Hom) principal investigator
Lecturer of the Department of Pathology & Microbiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized homeopathic medicines in people with Rhinitis; Allergic, With Asthma, run by Mahesh Bhattacharyya Homoeopathic Medical College and Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interleukin 10 and 13 level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.