| CTRI Number |
CTRI/2020/03/023837 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of an Ayurvedic formulation in the treatment of Chronic Simple Rhinitis(common cold). |
|
Scientific Title of Study
|
Randomized comparative cinical trial to study the effficacy of Katphaladi Churna and Tablet Levocetrizine[5mg] with Montelukast [10mg] in Peenasa Vyadhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Rochan Sharma |
| Designation |
MS Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
8729009998 |
| Fax |
|
| Email |
rochansrma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Madhukar Bhat |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9860233173 |
| Fax |
|
| Email |
vdpravin82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Madhukar Bhat |
| Designation |
Associate Professor |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9860233173 |
| 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 Rochan Sharma |
Sane Guruji Hospital,Hadapsar |
Opd no 9, Department
of Shalakyatantra,Sane
Guruji Hospital,
Malwadi road,
Hadapsar,
Pune-411028
Pune
MAHARASHTRA |
8729009998
rochansrma@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 |
| Intervention |
Katphaladi Churna |
Katphaladi churna, Orally 1 gm,(In two equal divided doses) with Koshna Jala (lukewarm water)for 15 days |
| Comparator Agent |
Levocetrizine, Montelukast |
Levocetrizine5mg in combination with Montelukast 10mg orally daily at night for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients from age group of 20 to 50 years.
2) Patients irrespective of gender and religion.
3) Patients having signs and signs and symptoms of Peenasaa Vyadhi(Chronic SimpleRhinitis) like Nasal Obstruction, Post-Nasal Drip, Partial loss of Smell(Anosmia). |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from known case of chronic specific infective rhinitis like Syphilis, leprosy, T.B. lupus Vulgaris, Rhinosporidiosis, Rhinoscleroma, fungal Infections, leishmaniasis.
2) Patients with systemic diseases and known case of Hypertension, Respiratory disorder, Diabetes Mellitus, HBsAg, HIV.
3) Patients with DNS, Nasal polyp, Asthma, Tumors or any nasal pathology.
4) Patient not willing for treatment and irregular follow up. |
|
|
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 |
A clinical study to evaluate efficacy
of Katphaladi Churna in Peenasa Vyadhi w.r.t Chronic Simple Rhinitis |
The drug will be given 15 days. 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 Katphaladi Churna and Tab Levocetrizine 5mg in combination with Montelukast 10mg in Peenasa Vyadhi w.r.t Chronic Simple Rhinitis |
Total duration of study is 18 Months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
MANUSCRIPT ON REVIEW PART IS READY BUT NOT SUBMITTED YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is open labelled randomized controlled clinical trial to evaluate the effect of Katphaladi Churna daily for 15 days in comparison with Tab Levocetrizine 5mg in combination with Montelukast 10mg of patients affected with Peenasa Vyadhi w.r.t Chronic Simple Rhinitis. The Primary outcome will be effect of Katphaladi Churna and the secondary outcome will be comparison between trial drug and control drug in management of Peenasa Vyadhi w.r.t Chronic Simple Rhinitis. |