| CTRI Number |
CTRI/2025/09/094865 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of herbal nasal inhalation therapy on people suffering from allergic nasal symptoms allergic rhinitis |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study on the Effectiveness of Ghritaguggulasikhta Dhoomnasya in the Management of Kshawathu with special reference to 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 |
Sukeshini Dadaji Moon |
| Designation |
PhD Student |
| Affiliation |
Government Ayurved college Nagpur |
| Address |
Department of shalakyatantra 2nd floor government ayurvedic college raghuji nagar near sakkardara chowk nagpur
Nagpur MAHARASHTRA 440034 India |
| Phone |
9960132094 |
| Fax |
|
| Email |
sukeshinimoons@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sukeshini Dadaji Moon |
| Designation |
PhD Student |
| Affiliation |
Government Ayurved college Nagpur |
| Address |
Department of shalakyatantra 2nd floor government ayurvedic college raghuji nagar near sakkardara chowk nagpur
Nagpur MAHARASHTRA 440034 India |
| Phone |
9960132094 |
| Fax |
|
| Email |
sukeshinimoons@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sukeshini Dadaji Moon |
| Designation |
PhD Student |
| Affiliation |
Government Ayurved college Nagpur |
| Address |
Department of shalakyatantra 2nd floor government ayurvedic college raghuji nagar near sakkardara chowk nagpur
Nagpur MAHARASHTRA 440034 India |
| Phone |
9960132094 |
| Fax |
|
| Email |
sukeshinimoons@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sukeshini Dadaji Moon |
| Address |
Plot no 76 Hudkeshwar road Bhande layout Nagpur 440034 Maharashtra India |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Sukeshini Dadaji Moon |
Governemt Ayurved Hospital Nagpur |
Opd no 38 1st floor government ayurved hospital raghuji nagar near sakkardara chowk nagpur Nagpur MAHARASHTRA |
9960132094
sukeshinimoons@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government Ayurvedic College Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J989||Respiratory disorder, unspecified. Ayurveda Condition: KSHAVATHUH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Sushruta Samhita, Procedure details: Dhumnasya/Nasal inhalaiton three inhaltion Two times a day for 7 days) (1) Medicine Name: Ghrutaguggula Sikhta Dhumvarti, Reference: Sushruta Samhita, Route: Nasal, Dosage Form: Varti/ Suppository, Dose: 10(g), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Xylomethazoline, Reference: PL Dhingra DIseases of ENT Head and neck surgery, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Study subjects suffering from allergic rhinitis
Study subjects of age group 7 to 80 years
Study subjects ready to give consent
|
|
| ExclusionCriteria |
| Details |
The following are general acceptance on the exclusion criteria for treatment of allergic rhinitis
Asthma with the exception of mild intermittent asthma
Chronic or intermittent use of inhaled oral intramuscular intravenous and or potent topical corticosteroids
Use of leukotriene modifiers
Use of long acting antihistamines
Documented evidence of acute or significant chronic sinusitis as determined by the individual investigator
Chronic use of concomitant medications eg antidepressants that would affect the assessment of the effectiveness of new treatment
A history of hypersensitivity to the product or its contents
Presence of rhinitis secondary to other causes
Planned travel outside the trial area for a substantial portion of the trial period
Systemic conditions such as DM HT HIV
Any severe life threatening confounding disorder
Malignancy polyps in nasal cavity |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in presence of eosinophils in nasal smear from baseline Day 0 to Day 7 |
Baseline and day 7th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="156" Sample Size from India="156"
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)
|
26/09/2025 |
| 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="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Title A Randomised Controlled Clinical Study On Effectiveness Of GhritaguggulsikthaVarti Dhum Nasya In The Management of Kshwathu With Special Reference To Allergic Rhinitis 02 Brief Introduction Allergic Rhinitis AR is caused by IgE immunoglobulin E mediated reactions to inhaled allergens and one of the most common chronic condition globally Allergic rhinitis generally found with allergic conjunctivitis and allergen Caused Asthma Various allergens like pollens tree grass weeds including ragweed moulds and indoor allergens like house dust mites and animal allergens are responsible for developing the allergic rhinitis Allergic Rhinitis likes to be the consequence of environmental exposure acting on a predisposing genetic factors AR is world health problem that causes major burden and disability of work AR responds to missed or unproductive time at work school sleeping problems and sufferers decrease the involvement in out door activities Allergic rhinitis affects the quality of life social life school and work and patient feels embracing because of paroxysmal sneezing1 Allergic Rhinitis is a highly prevalent Chronic disease which presents enormous global health burden It is estimated that at least 500 millions population have allergic rhinitis and common cause for attending the primary care practitioner2 The prevalence of Allergic Rhinitis has increased world wide since the 1960s in parallel to the increase in the prevalence of factors tendency to produce IgE antibodies owing to genetic or environmental factors3 The problem of Allergic Rhinitis is enormous constituting about 55 of all allergies about 2030 of Indian population suffers from Allergic Rhinitis Studies have shown that prevalence of Allergic Rhinitis has been increasing in India over past few years According to international study of Allergies in childhood ISSAC phase 1 1998 in India nasal symptoms alone were present in 125 children in 67 years age group and 196 in 1314 Years age group However in ISSAC phase 3 2009 study prevalence of nasal symptoms increased to 129 and 236 in 67 and 1314 years age groups respectively4 Allergic Rhinitis is characterized by sneezing nasal discharge rhinorrhoea nasal conjestion and nasal itching and blocking of nose5 According to Acharya Sushruta sneezing is present in other nasal disease also but it is separately mentioned as a separate disease itself term as Kshwathu Acharya Sushruta describes kzkkkfJrs eeZfk laiznqVs Lkfuyks ukfldk fujsfr AA11AA dQkuqkrks cgqk lkCnLra jksxekgq koFkqa fofkKk lqm 2211 It means when vitiated and aggrevated vata dosha passes to moordha through nasa pathway it irritates the nasa Ashrit Marma Shringataka Marma and creates Kshwathu Sneezing56 According to Sushrut Acharya also it has two types 1 Doshaj Kshwathu and 2 Aagantuj Kshwathu rhkksiksxknfrftkzrks ok Hkkoku dVwudZfujhkkkkAA lwkfnfHkZokZ rkkfLFkeeZqkfVrsU koFkqfuZjsfrA lqmv 2212 5 6 Because of Inhalation of tikshna dravya like Mustard Marich powder and other drug like Suntha Pippali Tobacco inhalation in higher doses observation of sunrays for more time entry of cotton thread into nasal cavity shringtaka marma irritates and causing sneezing called as Aagantuj kshwathu Ayurvedic treatment is the system of medicine which proposes the need of undertaking the clarification of biological system from gross channels upto molecular levels aiming to purification of entire body of vitiated factors which promotes prevention of diseases and promotion of health Solutions of this disease should be bidirectional as indicated by its vata and kapha dosha predominance Medication administered through nose to get desired therapeutic effects known as nasya therapy which acts on nasal mucosa Nasya can be advised in a person for treatment as well as prevention of diseases According to Charak Acharya Nasya karma is devided into five types 1Navana Nasya 2Avapidana Nasya 3 Dhmapana Nasya 4 Dhumanasya 5 Pratimarsha Nasya According to Acharya sushruta there are mainly 2 types of Nasya which are shirovirechana nasya and sneha nasya Apart from these other classification according to Acharya sushruta also five types Nasya shirovirechana nasya pratimarsh nasya avapidan nasya and pradhaman nasya 7 Navan Nasya the procedure of dropping the ghrita medicated oil into the nostril called as Navan nasya Eg Anutail Shadbindu tail nasya are the navan nasya Avapidan Nasya medicinal herbs are crushed into a paste and the squeezed to extract the juice which is dropped into the nostrils Dhmapana Nasya Pradhmana nasya Medicinal herbs are used in the fine powder and blown into the nostrils Pratimarsha Nasya Medicated oil dropped into the nostrils in a small and specific dose as 2 drops always DhumNasya smoke getting from burning the herbal medicinal plants is inhaled through the nostrils is called as Dhum Nasya It has 3 subtypes like prayogika dhum Vairechnik dhum and snahika dhum Drug are powdered and kept into a hollow stick and attached to the smoking pipe and its one end is lighted The smoke of it inhaled by nose 333 times This is the dose for prayogika nasya Length of prayogika dhumnetra is 36 angula and snaihika dhum netra is 32 angula and vairechanika dhumnetra is 26 angula So dhumnasya method is used for the treating the allergic rhinitis in my study Dhumpana and Dhumnasya are different Dhumpana is generally given after nasya karmaAfter nasya karma vitiated kapha accumulated into the nose and head developing various diseases so dhumpana is given in that case Dhumpana is mentioned by Acharya charak Dhumpana is the procedure in which medicated smoke is taken and emit from mouth and according to chakrapani in Dhumnasya medicinal herbs dhum is taken by Nasa and in dhumpana smoke is taken by the mouth7 STUDY RATIONALE The present study describes the evaluation and treatment of AR and highlights the role of ayurvedic doctors in improving care and treating allergic conditions alsoAR is knowns to peak in the second to forth decade of life which is more product full age Intranasal administration has assumed in the last years an increasingly value as an alternative strategy for the local absorption of drug to vascularized nasal mucosaSo dhumnasya will help to cure and prevent the AR It also include in daily routine procedure as dincharya Keeping this in view the present study will be carry out |