| CTRI Number |
CTRI/2020/12/029618 [Registered on: 07/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurvedic treatment in chronic simple rhinitis |
|
Scientific Title of Study
|
Randomized Controlled Trial To Evaluate Efficacy Of Nidigdhikadi Kwatha In Management Of Peenasa (Chronic Simple Rhinitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Sandip Patil |
| Designation |
MS Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 08, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8379890248 |
| Fax |
|
| Email |
patilsandip771@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAVIN M BHAT |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 08, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
09860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRAVIN M BHAT |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 08, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
09860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Tantra, Malwadi road, Hadapsar, Pune. |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya kendra, Malwadi road, Hadapsar, Pune. |
| 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 |
| Vd Sandip Patil |
Sane Guruji Arogya Kendra |
Opd no 8, Department
of Shalakyatantra,Sane
Guruji Arogya Kendra,Malwadi road,Hadapsar
Pune
MAHARASHTRA |
8379890248
patilsandip771@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J310||Chronic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levocetirizine(5mg) with Phenylephrine (10mg) |
Levocetrizine 5mg in
combination with Phenylephrine 10mg orally daily at night for 21 days |
| Intervention |
Nidigdhikadi Kwatha |
Nidigdhikadi Kwatha, Orally 20ml,(In single dose)
for 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients fulfilling the diagnostic criteria of Peenasa(Chronic Simple Rhinitis).
2) Patients suffering from three or more the following symptoms for more than one months were selected for study.( Nasal obstruction, Nasal discharge, Headache , Swollen turbinate’s, Post-Nasal discharge )
3) A patients having age group 18 to 60 years.
4) Patient willing to participate in the study.
5) Patients were recruited irrespective of sex, religion, occupation. |
|
| ExclusionCriteria |
| Details |
1) Pregnant women and Children.
2) Patients with history of congenital disorder of Nose.
3) Patients suffering from gross deviation of nasal septum and associated with other nasal pathology like nasal polyp etc.
4) Patients with uncontrolled systemic diseases like Diabetes Mellitus and Hypertension.
5) Chronic simple Rhinitis associated with Hyperthyroidism, Exanthemas, Adenoidal Hyperplasia, Choanal Atresia and Nasal Tumors.
6) Patient having Angle-Closure Glaucoma and Pyloric Stenosis. |
|
|
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 |
| Primary outcome will be evaluation of efficacy of Nidigdhikadi Kwatha in Peenasa Vyadhi w.r.t Chronic Simple Rhinitis |
The drug will be given for 21 days.The efficacy will be assessed on the basis of VAS SCALE for symptoms before and after treatment. The patients will be assessed before and after treatment. Total duration of the study will 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A comparison between efficacy
of Nidigdhikadi Kwatha and Tab Levocetrizine 5mg
in combination with Phenylephrine 10mg in
Peenasa Vyadhi w.r.t Chronic Simple Rhinitis will be done |
Total duration of study is 18 Months. Baseline assessment will be done of each patient before and after treatment. Each patient will be treated for 21days. Assessment will be done on VAS SCALE |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2021 |
| Date of Study Completion (India) |
02/09/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is open labelled randomized controlled clinical trial to
evaluate the effect of Nidigdhikadi Kwatha daily orally once in a day for 21days
in comparison with Tab Levocetrizine 5mg in combination with Phenylephrine 10mg
at night in patients affected with Peenasa Vyadhi w.r.t Chronic Simple Rhinitis.
The Primary outcome will be effect of Nidigdhikadi Kwatha and the secondary
outcome will be comparison between trial drug and control drug in management of
Peenasa Vyadhi w.r.t Chronic Simple Rhinitis |