| CTRI Number |
CTRI/2019/09/021365 [Registered on: 23/09/2019] Trial Registered Prospectively |
| Last Modified On: |
08/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Literary study of Veshtan Chikitsa from 3 main Ayurvedic Samhitas along with the role of covering of head,forehead and ear region in patients of rhinitis |
|
Scientific Title of Study
|
Literary study of Veshtan Chikitsa from Bruhatrayi with the role of Shiropariveshtan as Viharaj Chikitsa in patients of Pratishyay |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Hemangi Vasudeo Shendye |
| Designation |
B.A.M.S. |
| Affiliation |
|
| Address |
Deptartment of Basic Principles of Ayurved Samhita and Siddhant, Bharati Vidyapeeth College of Ayurved, Pune-Satara Road
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
hshendye@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Kulkrni |
| Designation |
B.A.M.S., M.D.(Ayu),Ph.D.(Ayu) |
| Affiliation |
Bharati Vidyapeeth College of Ayurved, Pune-Satara Road, Pune 411043 |
| Address |
Deptartment of Basic Principles of Ayurved Samhita and Siddhant, Bharati Vidyapeeth College of Ayurved, Pune-Satara Road
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
cureforsure@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemangi Vasudeo Shendye |
| Designation |
B.A.M.S. |
| Affiliation |
|
| Address |
Deptartment of Basic Principles of Ayurved Samhita and Siddhant, Bharati Vidyapeeth College of Ayurved, Pune-Satara Road
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
hshendye@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Medical Foundations College of Ayurved, Pune-Satara Road, Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Dr Hemangi Vasudeo Shendye |
| Address |
Department of Basic Principles of Ayurved Samhita and Siddhant, Bharati Vidyapeeth Deemed University, College of Ayurved, Pune-Satara Road, Pune-411043 |
| Type of Sponsor |
Other [self sponsered] |
|
|
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 Hemangi Vasudeo Shendye |
Bharati Vidyapeeth Medical Foundations College of Ayurved and Hospital, Pune |
Bharati Vidyapeeth Medical Foundations College of Ayurved and Hospital, Pune-Satara Road, Pune 411043
Pune
MAHARASHTRA |
8668270678
hshendye@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific Revieve Committee and Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Vyoshadi vati |
Vyoshadi vati
Dose-500mg after both the meals.
Administration route-Oral
Duration-5 days.
Comparating between effect of Vyoshadi vati with effect of Vyoshadi vati and Shiropariveshtan when given together |
| Intervention |
Vyoshadi vati and Shiropariveshtan |
Vyoshadi vati
dose-500mg after both the meals
Administration route-Oral
Duration-5 days.
Shiropariveshtan at night time, while travelling, while exposure to air.
Duration-5 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group-20yr.-60yr.
2)Patients of either gender.
3)Patients presenting any 4 symptoms as main symptom among following- kshavathu, nasa avarodh, atitrushna, shirashoola, gala-talu-oshtha shosh |
|
| ExclusionCriteria |
| Details |
1)Patients having nasal deformities like DNS,etc.
2)Patients with comorbidity like DM, HTN, malignancy,etc.
3)Patients with any surgical procedures done around or on nasal area and nose.
4)Injury due to fall on face, injuries due to accidents.
5)Patients having Pratishyay as a symptom or complication of any disease or complication of any surgical procedure.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be significant effect of Shiropariveshtan in patients of Pratishyay. |
3 to 4 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptoms of Pratishyay will be reduced. |
5-7 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 1 |
|
Date of First Enrollment (India)
|
23/09/2019 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Effect of Shiropariveshtan as Viharaj Chikitsa in patients of Pratishyay is seen in 2 to 4 days. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is enrolled with the aim to study effect of Shiropariveshtan as Viharaj Chikitsa in patients of Pratishyay. This is randomised parallel group active controlled trial, double group study with total sample size 120, including patients with 4 symptoms as main symptoms of Pratishyay, age group- 20 yr. to 60 yr. Shiropariveshtan will be followed as mentioned in Sushrut samhita. Medicine (Vyoshadi vati) and Shiropariveshtan will be given for 5 days. The primary outcome will be significant effect of Shiropariveshtan in patients of Pratishyay. The secondary outcome will be reduced symptoms of Pratishyay. |