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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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