| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | dhUmapAnam, धूमपानम् | (Procedure Reference: Astanga Hrudaya Sutrastana 21st chapter, Procedure details: Dhumapana given for the patients until samyak lakshana of dhumapana appear for 7days)))
| | 2 | Intervention Arm | Procedure | - | 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. |