| CTRI Number |
CTRI/2021/11/037952 [Registered on: 11/11/2021] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study held to see the effect of local application of alkali preparation of Arka plant in the management of nasal obstruction |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of arka kshara pratisarana in the management of nasa pratinaha (hypertrophied inferior nasal turbinates) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aiswarya Krishna |
| Designation |
MS Scholar Shalakya tantra |
| Affiliation |
Dr. D.Y. Patil College Of Ayurved And Research Centre |
| Address |
Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune, Maharashatra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8281022938 |
| Fax |
|
| Email |
aiswaryakrishna309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur Shiralkar |
| Designation |
Professor and HOD |
| Affiliation |
Dr. D.Y. Patil College Of Ayurved And Research Centre |
| Address |
Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune, Maharashatra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9422007951 |
| Fax |
|
| Email |
mayur.shiralkar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aiswarya Krishna |
| Designation |
MS Scholar Shalakya tantra |
| Affiliation |
Dr. D.Y. Patil College Of Ayurved And Research Centre |
| Address |
Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune, Maharashatra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8281022938 |
| Fax |
|
| Email |
aiswaryakrishna309@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune 411018, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Aiswarya Krishna |
| Address |
Dr. D.Y. Patil College Of Ayurved And Research Centre, Sant tukaram nagar, Pimpri, Pune 411018, Maharashtra |
| 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 |
| Aiswarya Krishna |
Dr D Y Patil college of Ayurved and Research Centre, Pimpri, Pune |
OPD NO: 4, Ground floor, Shalakya tantra OPD, Dr D Y Patil college of Ayurved and Research Centre, Sant tukaram nagar, Pimpri, Pune, 411018, Maharashtra
Pune
MAHARASHTRA |
8281022938
aiswaryakrishna309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: NASA PRATINAHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Susrutha Samhitha, Procedure details: • Patient will be asked to lie down in supine position with head extended by placing a pillow under the shoulder.
• Proper visualization of nasal cavity will be done with the help of 0 degree sinuscope.
• Nose will be packed with gauze dipped in Xylocaine 4% for a period of 5 min.
• Kshara will be taken with Jobson probe rolled with cotton and will be applied over the anterior surface of inferior turbinate.
• After 2 min, the probe will be withdrawn and colour of the turbinate wil)
(1) Medicine Name: Arka kshara, Reference: Shodhala nighantu, Route: Nasal, Dosage Form: Kshara, Dose: 0.5(mg), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having clinical features of Nasapratinaha(Hypertrophied inferior nasal turbinates) namely nasal congestion, nasal obstruction, trouble sleeping accompanied by mouth breathing and patients fulfilling atleast 2 of above criteria.
2) Patient between agegroup 18 and 60 years irrespective of their sex.
|
|
| ExclusionCriteria |
| Details |
1) Patient not willing for trial.
2) Nasal Obstruction due to reasons other than Hypertrophy of inferior nasal turbinates.
3) Patient with Epistaxis or other inflammatory conditions of nose.
4) Patient who need surgical and other intervention.
5) Pregnant &lactating women.
6) Hypertension, Malignancy, Diabetes mellitus.
7) Heart disease, Asthma, Anaemia.
8) Patient unfit for Ksharakarma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of ArkaksharaPratisarana in reduction of size of Hypertrophied inferior nasal turbinates. |
10 days with 2 followups(5,10) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Study of properties of ArkaKshara like Chedana, Ropana and Shothahara properties. |
10 days with 2 followups(5,10) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The aim of the study is to see the effectiveness of arka kshara pratisarana in the management of nasa pratinaha (hypertrophied inferior nasal turbinates). The study will be conducted with 30 patients showing signs and symptoms of nasa pratinaha, they will be administered with arka kshara for a duration of 10 days and followup will be done on 5th and 10th day and final conclusion will be drawn on the basis of proper statistical methods.
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