| CTRI Number |
CTRI/2023/07/054936 [Registered on: 07/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [CURATIVE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of katphala siddha taila nasal drop instillation in Rhinitis. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY OF KATPHALA SIDDHA TAILA PRATIMARSHA NASYA
IN RHINITIS. |
| Trial Acronym |
A Randomized Controlled Clinical Study of Katphala Siddha Taila Pratimarsha Nasya in Rhinitis |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajlaxmi Pisey |
| Designation |
MS Scholar Shalakya Tantra |
| Affiliation |
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and Hospital |
| Address |
Department of Shalakya Tantra, Bharati Vidyapeeth (Deemed to be university), College of Ayurved and Hospital, Satara road, Pune-411043, Maharashtra, India
Pune
MAHARASHTRA
411043
India |
| Phone |
7218550228 |
| Fax |
|
| Email |
rajlaxmipisey001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gajanan Patil |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Shalakya Tantra, Bharati Vidyapeeth (Deemed to be university), College of Ayurved and Hospital, Satara road, Pune-411043, Maharashtra, India
Flat no 7, tirthakunj apartment, aranyeshwar pune -43
Pune
MAHARASHTRA
411043
India |
| Phone |
9923037117 |
| Fax |
|
| Email |
drgajananpatil1984@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajlaxmi Pisey |
| Designation |
MS Scholar Shalakya Tantra |
| Affiliation |
|
| Address |
Department of Shalakya Tantra, Bharati Vidyapeeth (Deemed to be university), College of Ayurved and Hospital, Satara road, Pune-411043, Maharashtra, India
109/01, ward no 28, Ramnagar,wardha-442001
Pune
MAHARASHTRA
411043
India |
| Phone |
7218550228 |
| Fax |
|
| Email |
rajlaxmipisey001@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATI VIDYAPEETH DEEMED TO BE UNIVERSITY COLLEGE OF AYURVED PUNE |
|
|
Primary Sponsor
|
| Name |
Dr Rajlaxmi Pisey |
| Address |
Department of Shalakya Tantra, Bharati Vidyapeeth (deemed to be university), College of Ayurved and Hospital |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajlaxmi Pisey |
Bharati Vidyapeeth (Deemed to be university), College of Ayurved and Hospital, Pune. |
Department of Shalakya Tantra, Bharati Vidyapeeth (Deemed to be university), College of Ayurved and Hospital, Satara road, Pune-411043, Maharashtra, India
Pune
MAHARASHTRA |
7218550228
rajlaxmipisey001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Difficulty in breathing headache sneezing redness nasal discharge inflammation of nasal mucosa |
| Patients |
, (1) ICD-10 Condition:Z00-Z99||Factors influencing health status and contact with health services. Ayurveda Condition: NASAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | OXYMETAZOLINE NASAL DROP 0.05% | 2 DROPS IN EACH NOSTRIL TWO TIMES IN A DAY | | 2 | Comparator Arm | Procedure | - | Pratimarsha nasya | (Procedure Reference: Sushruta uttartantra chapter 24 , Procedure details: 2 drops in each nostril two times a day )
(1) Medicine Name: Katphala siddha taila , Reference: Sushruta sutrasthan chapter 38 , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting symptoms of Rhinitis (headache,difficulty in breathing,sneezing,redness,nasal discharge and inflammation of nasal mucosa) who are willing to participate will be selected. |
|
| ExclusionCriteria |
| Details |
Recently operated patients of nasal surgery, pregnant women or lactating women and those whose age are below 18 yrs and above 60 yrs will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS value to decrease in pain by 2-3, number of sneezing to decrease by 2-3 times/days, difficulty in breathing and inflammation of nasal mucosa to decrease from severe to moderate or moderate to mild will be considered as positive effect. |
8 days study with 4 follow up (2nd day,4th day,6th day and 8th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in redness, reduction in nasal discharge. |
8 days study with 4 follow up (2nd day,4th day,6th day and 8th day) |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
17/07/2023 |
| 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="0"
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
|
A randomized controlled clinical study of katphala siddha taila pratimarsha nasya will be done on 62 patients presenting with complaints of Rhinitis and they will be divided into 2 groups (A & B). Group A will be provided with the trial drug, katphala siddha taila and will be advised to instill 2 drops in each nostril in the morning and evening for 7 days. Group B will be provided with the control drug, Oxymetazoline nasal drop (0.05%) and will be advised to instill 2 drops in each nostril in the morning and evening for 7 days. Study will be conducted for 8 days and all observations will be taken and recorded starting from 0th day and follow up will be done 2nd day, 4th day, 6th day and on the 8th day observations will be taken for any recurrences. Data recorded will be analyzed statistically and conclusion will be drawn based on it. |