CTRI Number |
CTRI/2017/12/010937 [Registered on: 21/12/2017] Trial Registered Prospectively |
Last Modified On: |
25/02/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Ayurvedic treatment of Allergic Rhinitis |
Scientific Title of Study
|
Clinical evaluation of an Ayurvedic formulation in the management of Allergic Rhinitis-A pilot study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mata Shweta Pradipbhai |
Designation |
Research Officer Ay |
Affiliation |
Central Ayurveda Research Institute for Cardiovascular Diseases New Delhi |
Address |
Central Ayurveda Research Institute for Cardiovascular Diseases Punjabi Bagh Road no 66 Room no 202 New Delhi India
New Delhi DELHI 110026 India |
Phone |
|
Fax |
|
Email |
shwetamatadr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mata Shweta Pradipbhai |
Designation |
Research Officer Ay |
Affiliation |
Central Ayurveda Research Institute for Cardiovascular Diseases New Delhi |
Address |
Central Ayurveda Research Institute for Cardiovascular Diseases Punjabi Bagh Road no 66 Room no 202 New Delhi India
New Delhi DELHI 110026 India |
Phone |
|
Fax |
|
Email |
shwetamatadr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mata Shweta Pradipbhai |
Designation |
Research Officer Ay |
Affiliation |
Central Ayurveda Research Institute for Cardiovascular Diseases New Delhi |
Address |
Central Ayurveda Research Institute for Cardiovascular Diseases Punjabi Bagh Road no 66 room no 202 New Delhi India
New Delhi DELHI 110026 India |
Phone |
|
Fax |
|
Email |
shwetamatadr@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Ayurvedic Sciences 61-65 Institutional Area Janakpuri New Delhi |
|
Primary Sponsor
|
Name |
CCRAS |
Address |
61 65 Institutional area Janakpuri Delhi |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Mata Shweta |
CARICD New Delhi and Safadarjung Hospital Delhi |
ENT OPD, Second floor, CARICD New Delhi and
Room no 261 Clinical Research Unit (Ayurveda)Ring road opposite AIIMS hospital Sufadarjung west Delhi New Delhi DELHI |
8866014946
shwetamatadr@gmail.com |
Dr Parth Dave |
RRAP Central Ayurveda Research Institute for Cancer |
Room No. 4, OPD Unit Mumbai MAHARASHTRA
Mumbai MAHARASHTRA |
912224947259 91-222-4947822 parth.dave@gov.in |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
, Allergic Rhinitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Anu Taila NAsya
Ashwagandhadhi Yoga
Shirishadi Kwatha |
1) Anutaila- Nasya (6 drops in each nostril) -Ref.-A.H.Su.20/16
Dose : 06 ml
Dosage form : Oil
Route of administration : Nasal oleation (Nasya) 07 days for two consecutive cycles with the interval of 07 days
Time of administration Packing form : 10 ml plastic bottle
Duration of therapy : 04 weeks
2) Ashawagandhadi compound
i) Ashwagandha Churna-1gm Ref.-Bhavaprakash
ii).Sitopaladi Churna----- 2gm Ref.-Ch. Chi.8/103,104
iii) Abhrak Bhasma (Shatputi)250mg Ref.-Ay.Formulary of India,Part-1 ,18:1
iv)Sameerpannaga Rasa---- 65mg Ref.-Ay.Formulary of India, Part-1,15:08
v) Vishan Bhasma----------125 mg Ref.-Ay.Formulary of India, Part-1, 18:19
Dosage form : Powder
Route of administration : Oral
Time of administration : Twice a day after food
Anupana : Honey + Ghrita
Packing form : Pack containing 50 gm medicine
Duration of therapy : 04 weeks
3) Shirishadi Kashaya ---- Anubhuta yoga
Ingredients- Shirisha, Vasa, Kushtha, Kantkari, Madhuyashti, Pushkarmoola, Vibhitakibark, Haridra and Ajvayan.
Dosage form : Powder
Route of administration : Oral
Time of administration : Twice a day after food
Packing form : Pack containing 300 gm medicine
Duration of therapy : 04 weeks
Dose- 40 ml. twice a day (morning & evening).
|
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Patients either sex aged between 18 to 65 years.
2. Clinical diagnosis persisting symptoms of Allergic rhinitis, X-ray (PNS), Nasal endoscopy and laboratory investigations etc.
3. Able and willing to participate and provide signed informed consent.
|
|
ExclusionCriteria |
Details |
1. History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis.
2. History of non allergic rhinitis, chronic sinusitis or serve asthma.
3. Patients with nasal anatomical defects (deviated nasal septum).
4. Patients with acute episodes i.e. fever/earache/headache.
5. Patients with associated tonsillitis or airway obstructions (adenoids).
6. Has a nasal condition likely to affect the outcome of the study.
7. Any treatment of H1 antihistamine medication, Non-steroidal analgesies. Corticosteroids Nasal drops, Leukotriene antagonists, Nasal vasoconstrictors.
8. Pregnant ladies and Lactating mothers.
9. Patients suffering from any debilitating chronic disease like tuberculosis, Uncontrolled Diabetes mellitus
10. Any unstable cardio-vascular diseases
11. Patients with evidence of malignancy.
12. Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S. creatinine> upper limit of Lab. value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD])
13. Patient has an acute mental disorder
14. Patients who are currently participating in any other clinical trial.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the effect of Ayurvedic formulation in terms of Control of Allergic Rhinitis and Asthma Test |
one month |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not applicable |
Not applicable |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" |
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
|
16/04/2018 |
Date of Study Completion (India) |
10/04/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" 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)?
|
Brief Summary
Modification(s)
|
The very fact that while describing the diseases of nose in Sushruta Samhita, one separate chapter has been devoted to Pratishyaya in Uttartantra iterates the importance of the same; classified into five types on the pathological basis viz. Vataja, Pittaja, Kaphaja, Raktaja and Sannipataja. Though it has been said that the disease Pratishyaya in the initial phase, is a curable entity, in chronic course it may lead to Dushta Pratishyaya and then present with many associated complications with changed prognosis as well. On the basis of clinical features, Ayurvedic scholars today acknowledge to correlate Vataja Pratishyaya with Allergic Rhinitis (AR), a common ENT problem in modern literature. Because of being in direct contact with external environment nose is exposed to lot of microorganisms, allergens and environmental pollutants present in the atmosphere. If this stage is not properly treated, it will cause the mucosal changes in nostrils and result into turbinate hypertrophy, nasal polyps, allergic bronchitis etc. Allergic rhinitis is also associated with otitis media, Eustachian tube dysfunction, sinusitis, nasal polyps, allergic conjunctivitis, and atopic dermatitis. It may also contribute to learning difficulties, sleep disorders etc. The lack of curative treatment is necessitating the other health systems to provide a remedial treatment. The world has many expectations from Ayurvedic science in the treatment of AR.As mentioned earlier; AR is very much similar to Vataja Pratishyaya and as per the Ayurvedic literature, it is a curable disease. One research thesis work was carried out at I.P.G.T. & R.A., Jamnagar with the protocol of Ashwagandhadi compound, Shirishadi Kwatha and Anu Taila Nasya. Significant results were found in this research work. By keeping this fact in mind the same protocol has been proposed here. |