| CTRI Number |
CTRI/2020/03/023709 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| 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
|
Study of Chinchapatra Ghanvati and Bharangi Ghanvati in Pratishyaya(Common cold). |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate Efficacy of Chinchapatra Ghanvati with Bharangi Ghanvati in Pratishyaya of age group 8 to 16 years. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Nandlal Baldota |
| Designation |
PG STUDENT |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9921054524 |
| Fax |
|
| Email |
anandnbaldota111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Deodas |
| Designation |
HOD Kaumarbhritya |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
4110414
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Nandlal Baldota |
| Designation |
HOD Kaumarbhritya |
| Affiliation |
PDEAs College of Ayurveda And Research Centre Akurdi Pune |
| Address |
PDEAs College of Ayurveda And Research Centre Sector 25 Nigdi
Pradhikaran Pune Ayurved Rugnalaya And Sterling Multispeciality
Hospital Sector 27 Nigdi Pradhikaran Pune 44
Pune
MAHARASHTRA
411044
India |
| Phone |
9921054524 |
| Fax |
|
| Email |
anandnbaldota111@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research center, Third floor, Kayachiktsa Department, Nigdi,
Pradhikaran, Sector 25, pune 44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs College of Ayurved and Research center |
| Address |
PDEAs College of Ayurved and Research center, Nigdi, Pradhikaran,
Sector 25, pune 44 |
| Type of Sponsor |
Private medical college |
|
|
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 Anand Baldota |
Ayurveda Rungalay And Sterling Multispeciality Hospital Nigdi |
Vitthal Rukmini road,
Sector No 27, Nigdi
Pradhikaran, pune
411044, Name of
OPD-Kaumarbhritya,
OPD No. 118, Ground
floor, Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9921054524
anandnbaldota111@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: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bharangi Ghanvati |
Bharangi Ghanvati will be prepared by ghanvati kalpana and will be given orally with lukewarm water after meal twice a day includes follow up on every 3rd, 7th day |
| Intervention |
Chinchapatra Ghanvati |
Chinchapatra Ghanvati will be prepared by ghanvati kalpana and will be given
orally with lukewarm water after meal twice a day
includes follow up on every 3rd,7th day |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting with two or more symptoms like
Rhinorrhea,Sneezing, Nasal obstruction, Nasal
Itching, Headache
2 age - 8 yrs to 16 yrs of age
3 Gender - Male and Female |
|
| ExclusionCriteria |
| Details |
1 Mucoid and purulent or blood stained nasal discharge.
2 Patients having systemic illness.
3 Patients suffering from febrile illness.
4 Parents or guardians not willing for clinical trial
5 Patient suffering from nasal polyps, D.N.S.
6 Patients having Pratishyaya more than 7 days.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of Chinchapatra Ghanvati as per
weight twice a day with lukewarm water is as effective as
Bharangi Ghanvati as per weight twice a day with lukewarm water in Pratishyaya for 7 days. |
7 days with follow up on 3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the adverse effect of both if any
2 To compare efficacy of Chinchapatra Ghanvati
3 To compare efficacy of Bharangi Ghanvati |
7 days with follow up on 3rd and 7th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Rhinitis is one of the most common complaints in children seen all over world causing much discomfort in children. The international study of Asthma and allergies
in childhood noted the prevalence of rhinitis as 0.8 to 14.9% in
different countries throughout the world. Rhinitis causes various of symptoms, such as blocking of nose, sneezing, runny nose hence leads to an irritable child. Due to this parents get panic, hence a majority of patients are seen attending the opd with this complaint. According to modern medicine, varieties of causes are responsible for rhinitis such as environmental pollution, unnatural seasonal variation, dust, smoke etc.
Rhinitis can be compared in Ayurveda with disease Pratishay. It is described in Bruhatrai as well as Laghutrai, with its causes, signs and symptoms as well as management. Management of Pratishyaya in children needs more care and observation because the complication may make condition worst in the later stage of disease
|