| CTRI Number |
CTRI/2025/02/081273 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
TO COMPARE EFFECTIVENESS OF SALINE NASAL IRRIGATION AND HONEY WATER NASAL IRRIGATION IN TREATMENT OF ALLERGIC RHINITIS. |
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Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF JALA NETI AND MADHU NETI IN MANAGEMENT OF ALLERGIC RHINITIS VIS A VIS PRATISHYAYA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Balakrishna Patil |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and hospital,Mysuru |
| Address |
Department of swasthavritta, Government Ayurveda Medical College and Hospital,Visvesvaraya Circle, Devaraja Mohalla,Mandi Mohalla Mysore KARNATAKA
Mysore KARNATAKA 570001 India |
| Phone |
08698252013 |
| Fax |
|
| Email |
vandanagamc@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sudheendra G Nawale |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College and hospital,Mysuru |
| Address |
Department of swasthavritta, Government Ayurveda Medical College and Hospital,Visvesvaraya Circle, Devaraja Mohalla,Mandi Mohalla Mysore KARNATAKA
Mysore KARNATAKA 570001 India |
| Phone |
9341061821 |
| Fax |
|
| Email |
sudhi130207t@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vandana Balakrishna Patil |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and hospital,Mysuru |
| Address |
Department of swasthavritta, Government Ayurveda Medical College and Hospital,Visvesvaraya Circle, Devaraja Mohalla,Mandi Mohalla Mysore KARNATAKA
Mysore KARNATAKA 570001 India |
| Phone |
08698252013 |
| Fax |
|
| Email |
vandanagamc@gmail.com |
|
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Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Visvesvaraya circle,Devaraja Mohalla,Mandi Mohalla, Mysuru, Karnataka 570001 |
|
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Primary Sponsor
|
| Name |
Dr Vandana Balakrishna Patil |
| Address |
Government Ayurveda Medical College and Hospital, Mysuru |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandana Balakrishna Patil |
Government Ayurveda Medical College and Hospital |
Room no 12 Department of Swasthavritta and Yoga Government Ayurveda Medical College and Hospital Mysore KARNATAKA |
08698252013
vandanagamc@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda Medical College and hospital Mysuru |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Madhuneti | (Procedure Reference: Previous study by Dr Archana Inchekar 1997 to 2001 Kerala University, Procedure details: 1 Fill the Neti pot with lukewarm Honey water. 2 Stand with the legs apart. 3 Hold the Neti pot in your right hand. 4 Insert the nozzle of the Neti pot into the right nostril. 5 Keep the mouth open & breathe freely through the mouth. 6 Tilt the head first slightly backward, then bend forwards & move the neck sideward to the right so that the water from the pot enters the right nostril & comes out through the left by gravity. Allow the flow till the pot is empty. 7 Repeat the same on the left side. 8 To clear the nasal passages of the remaining water, blow out the water by active exhalation through alternate nostrils. Post procedure - Kapalabhati 2 to 3 rounds)
| | 2 | Intervention Arm | Procedure | - | Jalaneti | (Procedure Reference: Hatayoga Pradeepika 2/21 and 2/30, Procedure details: 1 Fill the Neti pot with lukewarm saline water.
2 Stand with the legs apart.
3 Hold the Neti pot in your right hand.
4 Insert the nozzle of the Neti pot into the right nostril.
5 Keep the mouth open & breathe freely through the mouth.
6 Tilt the head first slightly backward, then bend forward & move the neck sideward to the right so that the water from the pot enters the right nostril & comes out through the left by gravity. Allow the flow till the pot is empty.
7 Repeat the same on the left side.
8 To clear the nasal passages of the remaining water, blow out the water by active exhalation through alternate nostrils.
Post Procedure Kapalabhati 2-3 rounds.)
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects having age groups between 18 to 50 years. irrespective of caste religion and genders.
2 Subjects having classical symptoms of Allergic rhinitis.
3 Subjects having willing to participate in study |
|
| ExclusionCriteria |
| Details |
1 Subjects having recent surgical history.
2 Subjects having Nasal growths Severe DNS Asthma Prone to Ear infection.
3 Uncontrolled Hypertension Uncontrolled Diabetes Mellitus or any other systemic disorders.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the effect of Jala Neti in the management of Allergic rhinitis (Pratishyaya)
2 To evaluate the effect of Madhu Neti in the management of Allergic rhinitis (Pratishyaya) |
16 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Jala Neti and Madhu Neti in the management of Allergic rhinitis (Pratishyaya) |
16 Days |
|
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Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Allergic rhinitis is a disorder in which there are episodes of nasal congestion, watery nasal discharge and sneezing, may be associated with conjunctival and pharyngeal irritation and sinusitis, It may be due to an immediate hypersensitivity reaction in the nasal mucosa. Allergic rhinitis is a common problem in today’s world, currently from the overall population approximately 10-30% of adults and 40% of children are affected.In India, approximately 22% of adolescents currently suffer from allergic rhinitis. Although Allergic rhinitis is not a fatal condition, it is associated with impaired quality of life, absenteeism from work, and substantial financial costs. The Contemporary treatments are antihistamines and anti-allergic drugs although they have quick action when these fail to control symptoms or produce intolerable side effects, Alternative Medical sciences like Yoga can be helpful in management. The Causative factors and symptoms of Allergic Rhinitis have similarities with Pratishyaya, which is a Nasagata Roga. Sushruta Samhita explained Pratishyaya as a condition in which Kapha, Pitta, and Rakta along with Vata accumulate in the head region. The etiological factors for Pratishyaya are Rajo Sevana, Ritu Vaishamya, Avashyaya and Dhooma, This helps us to correlate it with Allergic rhinitis. If Pratishyaya is not treated properly, it leads to a severe and complicated condition called Dushta Pratishyaya. which is difficult to manage. Pratishyaya is an Urdhwajatrugata Roga and Neti is beneficial in curing ailments involved in the supraclavicular region. Hata Yoga Pradipika and Gherand Samhita described Shatkarma as six purificatory procedures to be practiced when kapha and Medas are in excess (Dhauti, Basti, Neti, Nauli, Trataka, Kapalabhati). Neti is a technique to cleanse the nasal passages. Neti cleanses Kapala, gives clear vision and alleviates disease which manifest above the root of the neck. Repeated irrigation of the nasal passage helps in reducing congestion in the nasal passage and swelling. Saline nasal irrigation can significantly improve symptoms of Allergic rhinitis in children and adults, it can serve as a safe adjacent treatment in adults. Honey used in madhu neti has a potential therapeutic role in the treatment of disease by anti-inflammatory, antibacterial and antioxidant properties. According to Sushruta Samhita, the qualities of honey are Shodhana, Ropana, Prasadana, Sukshmamarganusari, Kaphaghna and Tridosha-prashamana. In current study we are trying to compare the efficacy of Jala neti and madhu neti in the management of Allergic rhinitis vis a vis Pratishyaya. |