| CTRI Number |
CTRI/2020/10/028224 [Registered on: 05/10/2020] Trial Registered Prospectively |
| Last Modified On: |
03/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of panchlavan siddha ghritpan in Allergic rhinitis |
|
Scientific Title of Study
|
A controlled phase 2 clinical study to evaluate the efficacy of panchalavan siddha ghrit orally in Vataj pratishyay with special reference to Allergic rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Balajirao Shrikhande |
| Designation |
PG Student |
| Affiliation |
Ayurved Seva Sangh Arogyashala Rugnalaya Nashik |
| Address |
OPD No 13 Kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
7588390667 |
| Fax |
|
| Email |
pshrikhande0107@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan B kulkarni |
| Designation |
HOD and Professor |
| Affiliation |
Ayurved Seva Sangh Arogyashala Rugnalaya Nashik |
| Address |
OPD No 13 Kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9579523658 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan B kulkarni |
| Designation |
HOD and Professor |
| Affiliation |
Ayurved Seva Sangh Arogyashala Rugnalaya Nashik |
| Address |
OPD No 13 Kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9579523658 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Priyanka Balajirao Shrikhande |
|
|
Primary Sponsor
|
| Name |
Aarogyashala Rugnalaya Nashik |
| Address |
Ganeshwadi Panchavti Nashik |
| Type of Sponsor |
Other [Govt Medical Grant In Aided Collage] |
|
|
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 Priyanka Balajirao Shrikhande |
Arogyashala Rugnalaya Nashik |
OPD No 13 Kayachikitsa Department
Nashik
MAHARASHTRA |
7588390667
pshrikhande0107@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurved Seva Sangh Ayurved Mahavidyalaya Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Panchlavan siddha ghrit |
30ml once a day for 7 days |
| Comparator Agent |
Tab citrizine |
10mg once a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients With sign and symptoms of Allergic Rhinitis like jalvatnasastrav kshavathu Anaddhapihitanasa Shirashool swarbhed |
|
| ExclusionCriteria |
| Details |
Patient with major illness like uncontrolled hypertension and diabetes mellitus tuberculosis and malignancy cardiac diseases etc
Pregnant women and lactating women
Severe obstruction of nasal cavity that is severe DNS Adhesions Nasal polyps in the nasal cavity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of sneezing |
in 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of rhinorrhoea |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
09/10/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Now a days there are some diseases which are need to be given special attention changing life style increased pollution urbanisation and increased resistence to antibiotic are responsible for prevalence of many diseases one of them is allergic rhinitis Allergic rhinitis symptomatic disorder of the nose induced after allergen It is clinically defined as symptomatic condition with four major symptoms as anterior or posterior rhinorrhea sneezing nasal itching nasal congestion Also include watering of eye swelling around the eyes considering nature of the disease and limited option in the modern science it encourages to find out perfect remedy for this burning problem of the society Hence i selected the panchlavan siddha ghrit orally in vataj pratishyay Allergic rhinitis is one of the prime disease of rhinilogy found in all age group its clinical manifestation very much similor to vataj pratishyay described in ayurveda Indulgence in un salutery life style and food habits like consuming ice cream cold drinks exposure to air conditionars or coolers Also the present century driving the human to use extra of his energy in every kind such as physical mental social environmental etc. leads to many emotional and climatic changes in the humen body results in vitation of vata and person who are unable to bear these changes suffer from allergic rhinitis that is vataj pratishayay There is no specific treatment available in modern science for allergic rhinitis thats why in ayurved samhita opportunity to treat Allergic Rhinitis with the help of panchlavan siddha ghrit orally in vataj pratishayay |