FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094849 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Darvyadhi Dhumapana and Trivritadi Dhumapana in Kaphaja Pratishyaya 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Darvyadhi Dhumapana and Trivritadi Dhumapana in Kaphaja Pratishyaya (Chronic Simple 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  Dr Divyasri R N 
Designation  P G Scholar 
Affiliation  Alvas Ayurveda Medical College and Hospital 
Address  Department of Shalakyatantra Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,D.K Karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7019417206  
Fax    
Email  divyashrirn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sathisha Shankara B 
Designation  Professor 
Affiliation  Alvas Ayurveda Medical College and Hospital 
Address  Department of Shalakyatantra Alvas Ayurveda Medcical College and Hospital, Vidyagiri, Moodubidire,D.K Karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9482167168  
Fax    
Email  drsatish88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Divyasri R N 
Designation  P G Scholar 
Affiliation  Alvas Ayurveda Medical College and Hospital 
Address  OPD of PG Department of Shalakyatantra Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,D.K Karnataka

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7019417206  
Fax    
Email  divyashrirn@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, D.K, Karnataka 574227 
 
Primary Sponsor  
Name  Dr Divyasri R N 
Address  Alvas Ayurveda Medical College and Hosital, Vidyagiri, Moodubidire, D.K, Karnataka 574227 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divyasri R N  Alvas Ayurveda Medical College and Hospital  PG Studies in the Department of Shalakya tantra,Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire
Dakshina Kannada
KARNATAKA 
7019417206

divyashrirn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodubidire, Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-dhUmapAnam, धूमपानम् (Procedure Reference: Astanga Hrudaya Sutrastana 21st chapter, Procedure details: Dhumapana given for the patients until samyak lakshana of dhumapana appear for 7days)))
2Intervention ArmProcedure-dhUmapAnam, धूमपानम् (Procedure Reference: Astanga Hrudaya Sutrastana 21st chapter, Procedure details: Dhumapana given for the patients until samyak lakshana of dhumapana appear for 7days))
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  a) Age group of 12-35 yrs
b) Paticnts having the signs and symptoms of Kaphaja Pralishyaya
c) Patient indicated for Dhumapana
 
 
ExclusionCriteria 
Details  Paticnts having
a) Other than Kaphaja Pratishyaya (Vata, Pilta, Rakta, Sannipata)
b) Chronicity of the disease more than I year
c) Contraindicated for Dhumapana°
d) Nasal polyp, Epistaxis, Tumors of nose
e)Atrophic Rhinitis, Hypertrophic Rhinits, Rhinitis Sicca, Rhinitis Caseosa, Non-
Infective Rhinitis
f) Subjects having history of HTN, DM and other systemic disorders
g) Pregnant and Lactating women
h) Patients who has undergone Septoplasty, Sub Mucous Resection operation. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in clinical signs and symptoms of Kaphaja Pratishyaya (Chronic Simple Rhinitis) such as
Nasasrava
Kandu
Shirogourava
Aruchi
Kasa
Reduced smell perception

 
0th,7th,14th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To evaluate the efficacy of Darvyadi Dhumapana in the management of Kaphaja Pratishyaya.
2) To evaluate the efficacy of Trivritadi Dhumapana in the management of Kaphaja Pratishyaya.
3) To compare & evaluate the efficacy of Daryadi Dhumapana & Trivritadi Dhumapana in the management of Kaphaja Pratishyaya 
14days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="14" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Nose is one among the five sense organs and is considered as gateway to the head. Acharyas quote that ’Nasa hi shiraso dwaram’ which makes it a prime route for medicinal administration and even tends to be prone to reccurrent infections. Acharyas has mentioned many Nasagata Vikaras with its line of management, amongst which Pratishyaya is the most comimon one. Pratishyaya occurs when Kaphadi doshas travel against the Gati of Vata resulting in Siradhmana and being eliminated through the nostrils. Among the five mentioned Pratishyaya’s, Kaphaja Pratishyaya is commonly observed. Considering the signs and symptoms Kaphaja Pratishyaya can be corelated to Chronic Simple Rhinitis . Rhintis is the inflammation of the mucosal lining of the nostil characterized with anterior and posterior rhinorrhea, sneezing, nasal blockage and itching of the nose. Prevalence of Chronic Rhintis is 30-40 percent in general population. Chronic Simple Rhinitis has similar features, with marked post nasal drip and nasal blockage and the nasal secretion become thick and viscid. Causative factors of Rhinitis includes allergy(most common), virus, bacteria, seasonal variations, suppression of natural urges can be potent to initiate the pathology. Treatment of Chronic Simple Rhintis in modem science includes nasal decongestant sprays, long term use of continuous positive airway pressure(CPAP) machines which results in conditions like Rhinitis medicamentosa.
Hence this is an effort to evaluate the efficacy of Darvyadi Dhumapana and Trivritadi Dhumapana in Kaphaja Pratishyaya.
 
Close