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CTRI Number  CTRI/2023/11/059458 [Registered on: 02/11/2023] Trial Registered Prospectively
Last Modified On: 15/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Allergic Rhinitis by Homoeopathic Medicines 
Scientific Title of Study
Modification(s)  
Single Blind Randomized Study to Evaluate Efficacy of Solanium Lycopersicum in Comparison with Individualized Homoeopathic Medicines in Cases of Allergic Rhinitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishnaben Raj 
Designation  PhD scholar 
Affiliation  Parul University 
Address  OPD no. 111, Department of practice of medicine, Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  07383869199  
Fax    
Email  krishna.raj93649@paruluniversity.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tarunkumar Das 
Designation  Proffessor in Department of Materia Medica(P.G.),PhD Guide 
Affiliation  Parul University 
Address  OPD no. 111, Department of practice of medicine, Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  9376225507  
Fax    
Email  jnhmc@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnaben Raj 
Designation  PhD scholar 
Affiliation  Parul University 
Address  OPD no. 111, Department of practice of medicine, Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  7383869199  
Fax    
Email  krishna.raj93649@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Homoeopathic Medical College and Hospital 
 
Primary Sponsor  
Name  Parul University 
Address  Jawaharlal Nehru Homoeopathic Medical College and Hospital. P.O.Limda. Waghodia - 391760. Vadodara. Gujarat. India. 
Type of Sponsor  Private medical college 
 
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 Krishnaben Raj  Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University,  OPD no. 111, Department of practice of medicine, Jawaharlal Nehru Homoeopathic Medical College and Hospital. Parul University. Limda. Waghodia. Vadodara GUJARAT
Vadodara
GUJARAT 
07383869199

krishna.raj93649@paruluniversity.ac.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Jawaharlal Nehru Homoeopathic Medical College and Hospital. Institutional Ethics Committee for Human Research  Approved 
Jawaharlal Nehru Homoeopathic Medical College and Hospital. Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Selection of Homoeopathic Medicine will be based on individualization, after proper analysis, evaluation and miasmatic analysis of the case as per homoeopathic principles  Selection of Homoeopathic medicines, Dosages and repetition will be strictly according to the homoeopathic principles. Each dose will be directed to be taken orally on clean tongue with empty stomach. Duration of therapy 6 months with follow up at every 15 days. 
Comparator Agent  treatment of Allergic Rhinitis with SOLANIUM LYCOPERSICUM  all the other instructions will be same as intervention arm except this arm will receive SOLANIUM LYCOPERSICUM. This need to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Duration of therapy: 06 months with follow up at every 15 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  >Newly diagnosed and pre-diagnosed cases of Allergic Rhinitis.
>Diagnosed cases of Allergic Rhinitis who have taken medicines from any other system of treatment like Allopathy, Ayurvedic, etc. will also be considered after a washout period of 15 days.
>Patients who have previously taken Homoeopathy medicines prior to the visit were also taken into consideration after 1 month of washout period.
>The patients who have given their consent to participate in study with follow ups.
 
 
ExclusionCriteria 
Details  >The cases which did not fulfil the inclusion criteria.
>Patient having Allergic Rhinitis in association with other autoimmune disorders.
>Patients with other respiratory diseases and other systemic illness (Diabetes Mellitus, Metabolic Syndrome, Cardiovascular diseases, Endometrial neoplasia) etc. Rhinitis secondary to anatomical abnormalities or any other complications.
>Pregnant women and lactating mothers.
>Patients not giving written consent.
>Cases with irregular follow up.
 
 
Method of Generating Random Sequence
Modification(s)  
Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking
Modification(s)  
Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
improvement of symptoms with decreased frequency of Allergic Rhinitis  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the quality of life  6 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 
Date of First Enrollment (India)   02/11/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Allergic rhinitis is considered to be a risk factor for asthma development. People with allergic rhinitis have three times higher chance of developing asthma. Interestingly, the relief of allergic rhinitis symptoms over a time is associated with the improvement of asthma symptoms. The incidence of asthma and allergic rhinitis also increase with age. In addition to nasal and ocular symptoms directly related to the allergic process, interference of these symptoms with sleep leads to daytime sleepiness and impaired quality of life. Patients miss work because of symptoms but an even greater problem is interference with work productivity, which has been reported to be the biggest contributor to the total economic cost of allergic rhinitis. Allergic rhinitis adversely affect behavior, work performance and lifestyle. allergic person is more hypersensitive towards certain allergens while the healthy person is not. A proper homeopathy treatment for allergy helps to change that hypersensitivity of the person. It helps to modify the hyper susceptibilities of the person. When the hypersensitivity or the hyper susceptibility of the person is modified, then he will not react adversely to the harmless allergens which he was reacting earlier. This can only be possible by a proper constitutional homeopathy treatment by taking the totality of symptoms. Homeopathy treatment acts at the body’s deep seated energetic level. It is because the hypersensitivity of the person makes his immune cells to react adversely to the normal substances. A proper homeopathy treatment fixes that problem at the root level and makes that person healthy.

Aim is to ascertain the role of solanium lycopersicum and individualized Homoeopathic medicines in the treatment of Allergic Rhinitis.

 


 
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