| CTRI Number |
CTRI/2025/04/085616 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of chaturjatak churna pradhaman nasya in management of kaphaja pratishyaya(chronic simple rhinitis) |
|
Scientific Title of Study
|
A randomised controlled clinical trial to study the effect of chaturjatak churna pradhaman nasya in management of kaphaja pratishyaya with reference to 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 Prajakta Rajpal Shinde |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
OPD NO 16 SHALAKYATANTRA DEPARTMENT SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
9561998126 |
| Fax |
|
| Email |
shindeprajakta127@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Tushar Firake |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
OPD NO 16 SHALAKYATANTRA DEPARTMENT SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403
MAHARASHTRA
Nashik
MAHARASHTRA
422403
India |
| Phone |
9850447661 |
| Fax |
|
| Email |
petalsayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Tushar Firake |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
OPD NO 16 SHALAKYATANTRA DEPARTMENT SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403
MAHARASHTRA
Nashik
MAHARASHTRA
422403
India |
| Phone |
9850447661 |
| Fax |
|
| Email |
petalsayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Rajpal Shinde |
| Address |
OPD NO 16 SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
| 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 Prajakta Rajpal Shinde |
SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
OPD NO 16 SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA |
9561998126
shindeprajakta127@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved college and Hospital |
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 | Intervention Arm | Drug | Other than Classical | | | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Chaturjatak churna , Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Chaturjatak churna pradhaman nasya 125mg bd in early morning | | 3 | Comparator Arm (Non Ayurveda) | | - | Xylometazoline hydrochloride | Xylometazoline hydrochloride nasal decongestant solution 0.5% w/v |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients fulfilling clinical features of kaphaja pratishyaya
2)Patients between age 18 to 60 years
3)Selection of patient will be irrespective of their sex,religion,socioeconomic status |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from systemic disorders like DM,HTN,HIV,HBsAg
2)Patients age below 18 years and 60 years above
3)Patients having complications of kaphaja pratishyaya |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of kaphaja pratishyaya after administration of chaturjatak churna pradhaman nasya |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where trial group stands in comparison with control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
08/05/2025 |
| 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" |
|
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
|
Most of the people are suffering from respiratory disorders due to air-water polution & climate changes.Rhinitis is the inflammation of inner-lining af nose. Poor dietary habits, genetic predisposition, awful lifestyle triggers the pathogenesis of Pratishayaya. Pratishayaya is Kaphavata predominating disease which involves Vitet vitiation of Pranavaha & Rajavaha srotas.
Previshaya is Characterized by nasal blockage, whitish thick nasal discharge, headache, heaviness in head, itching. This disease leads to immune compromise condition in its chronic phase. Kaphaja Pratishayaga in general is similar to that of chronic simple rhinitis in modern science
Chaturjatak churna is used for pradhaman nasya in Kaphaja Preatishayaya. It contains Twak, Ela, Tejpatra,Nagkeshar. It has Ushna virya, katu vipak & vatakaphahara Properties. Also chaturjatak churna has Anti inflammatory properties which when taken together will be found beneficial in treating kaphaja pratishyaya so chajurjatarak churna is used as a best alternative to xylometazoline hydrochloride decongestant Solution.
Inclusion criteria has patients fulfilling clinical feature of Kaphaja pratishayaya, Age group of 18 to 60 years,
Exclusion Criteria has patients with systemic disorders like DM, HTM HIV, HBsAg, Patients below age 18 & above 60 yrs age. Patients having complications of kaphaja pratishyaya. Computerised generated sampling technique is will be used. Total 70 no of patients will be selected & divided into 2 groups, Group A-trial Group-chaturjatak churna(3munchyuti)& Group B- xylometazoline hydrochloride (2drops) Both drugs will be administered for 7 days with nasal route of administration.Observations will be made on 3rd, 5th, 7th and a 15th day.Result will be drawn on the basis of criteria of assessment a Statistical analysis.Discussion will be made on the basis of observations and result obtained during treatment.Summary will drawn & thesis work will be done. Conclusion will obtained based on statistical analysis and will be unbiased.
|