| CTRI Number |
CTRI/2019/11/022029 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Ayurveda and Homeopathy in Common Cold |
|
Scientific Title of Study
|
An Integrated Approach In The Management Of Allergic Rhinitis – A Randomised Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Associate Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi - 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajashekhar V Sanapeti |
KLE Ayurveda Hospital |
OPD no 04 and IPD of KLE Ayurveda Hospital Shahapur Belagavi - 590003 Belgaum KARNATAKA |
9611442881
rajashekharpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHERs Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J308||Other allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Homoeopathic treatment |
Allium cepa
Arsenicum album
Euphrasia officinalis
Silicea
Sabadilla
Kali Carb
Arum triphyllum
Dulcamara
Nux Vomica
Hepar sulph
Drugs will be administered orally in ectract form and dose prescribed is beginning will be 30 followed by 200 and 1 M. for 6 months |
| Intervention |
Shodhana chikitsa followed by Homoeopathic treatment |
1-2 year chronic
Deepana Pachana with orally Chitrakadi vati
2 bd, B / F or
Vyoshadi vati
1 tid A / F
Shiro – Virechana Nasya with
Guda-nagar swarasa 8 drops each nostrils For 7 days
Purvakarma – Stanika abhyanga with Nirgundi taila, Nadi sweda
Paschat karma – Dhoomapana and Kavala with Triphala+ Yasti + Haridra + Saindhava lavana
2 year onwards
Deepana Pachana with orally Chitrakadi vati
2 bd, B / F or
Vyoshadi vati
1 tid A / F
Koshta shodhana with Gandharva hastadi castriol – 30 ml + Ksheera – 60 ml
Shiro – Virechana Nasya with Shadbindu taila 10 - 12 drops each nostrils For 7 days
(Purvakarma – Stanika abhyanga with Nirgundi taila, Nadi sweda
Paschat karma – Dhoomapana and Kavala with Triphala+ Yasti + Haridra + Saindhava lavana)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with the Symptoms of Allergic Rhinitis
Either sex
Fit for Shodhana treatment
|
|
| ExclusionCriteria |
| Details |
Cases with gross nasal pathological changes like DNS, Nasal polyps, chronic sinusitis, any other nasal tumors
Complications affecting the lower respiratory system like pneumonia, asthma etc.,
Patients on immune suppressants
Associated with Systemic diseases, pregnant woman
Cases coming out with symptoms other than these 10 remedies included in research will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Integrated protocol is beneficial |
10th day
30th day
60th day
90th day
120th day
150th day
180th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/12/2019 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
— Allergic
Rhinitis a disease pertaining to Nose, induced by an immunoglobin E
(IgE)-mediated inflammatory reaction after allergic exposure of the membranes
lining the nose and is characterized by watery Nasal discharge, Nasal
congestion, Sneezing and Itching in the nose1. Allergic rhinitis is
the most common type of chronic rhinitis, affecting 10 to 20% of the
population, and evidence suggests that the prevalence of the disorder is
increasing2. Severe allergic rhinitis has been associated with
significant impairments in quality of life, sleep and work performance3 Most
cases of Allergic Rhinitis respond to pharmacotherapy. Patients with
intermittent symptoms are often treated adequately with oral antihistamines,
decongestants, or both as needed. Regular use of an intranasal steroid spray
may be more appropriate for patients with chronic symptoms. Daily use of an
antihistamine, decongestant, or both can be considered either instead of or in
addition to nasal steroids4. Anti-histamines
relieve the symptoms temporarily and in addition it may lead to side effects
like drowsiness or sedation, dryness of mouth, suppressing of appetite but
avoidance of allergens or desensitization against the allergens is the ideal methods
to avoid Allergic Rhinitis but these are not always possible. Allergic
rhinitis mimics lakshanas of Vataja Pratishyaya which is a Nasagataroga and one
among five types of Pratishyaya5 Panchakarma (Shodhana - biopurificatory) treatments will eliminate the morbod factors
responsible for the genesis of disease6 and are proved effective in
the management of Allergic Rhinitis (Pratishyaya). Panchakarma treatments will
boost the immune system and can prevent recurrent episodes of Allergic Rhinitis7.
Vamana karma (Theraupetic Emesis) / Virechana (Therapeutic Purgation) / Nasya
(Errhine) karma are Shodhana procedures
that eliminate morbid Kapha dosha and thereby removing the allergens out of the
body. Homeopathy
is safe and effective way to treat AR, which also decreases the recurrence of
symptoms due to its influence on vital force and will trigger the body’s
natural defences. Medicines are prescribed on the basis of symptom similarity. Homeopathic
medicine stimulates the body’s own defense system to cope with exposure to
allergens, rather than suppressing the allergic symptoms. Often, treatment
doesn’t have to be taken continuously – for example, a homeopathic medicine
taken at the begining of allergic rhinitis and can be repeated every month till
the episodes and intensity of symptoms decreases8
With
this background here is an attempt made to find out effective treatment of
homoeopathic formulation to treat Allergic rhinitis along with Panchakarma (purifactory
process) of an Ayurveda and its efficacy to prevent recurrent episodes. So the
formulations which are explained in the treatment of Allergic rhinitis have
been selected for the present study those are constitutional approach of homoeopathy
and integrated approach of Ayurveda. So present study is aimed to know the
efficacy and safety of these formulations in the management Allergic
rhinitis. |