| CTRI Number |
CTRI/2024/08/072973 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare the efficacy of shatyadi churna versus tulasi patra churna in common cold in 6-12 yrs of age group |
|
Scientific Title of Study
|
Comparative study of efficacy of shatyadi churna and tulasi patra churna in the management of pratishyaya of children in age group of 6-12 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajnandini Janardan Kadam |
| Designation |
Post Graduate Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli MAHARASHTRA 416301 India
Sangli
MAHARASHTRA
416301
India |
| Phone |
9175307268 |
| Fax |
|
| Email |
rajnandinikadam19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Chaugule |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921212722 |
| Fax |
|
| Email |
chaugulemahesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Chaugule |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Balrog Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9921212722 |
| Fax |
|
| Email |
chaugulemahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Maharashtra India 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Rajnandini Janardan Kadam |
| Address |
OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajnandini Janardan Kadam |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 10 Balrog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9175307268
rajnandinikadam19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Sangli Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: tulasi patra churna, Reference: Ashtang hriday 15/30-31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.8(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: mishri), Additional Information: -dosage varying by age | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shatyadi churna, Reference: Yogratnakar Nasarogchikitsa 7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.8(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ghruta + gudh), Additional Information: -dosage varying by age |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients presenting symptoms of all types of Pratishyaya mentioned in ayurveda within 7 days
2 irrespective of sex socioeconomic status and religion
3 children of age group of 6 to 12 years |
|
| ExclusionCriteria |
| Details |
1 Chronic debilitating disease or disorders like CA TB and congenital anomalies related respiratory system
2 Duration of symptoms more than one week
3 Raktaj and Dushta Pratishyaya and having fever |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate efficacy of shatyadi churna and tulasi patra churna in pratishyaya by using assessment criteria as given
On the basis of subjective parameters like running nose sneezing nasal blockage kasa headache loss of taste nasal itching and objective parameter like CBC before and after treatment with 7 days follow up
On the basis of statistical analysis
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare the efficacy of shatyadi churna & tulasi patra churna in the management of pratishyaya by using assessment criteria as given
On the basis of efficacy comparision in Subjective & objective parameters before & after treatmeters with 7 days follow up
On the basis of statistical analysis
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As we see day by day number of patients suffering from Pratishyaya commonly occurs with irritation so this study will help the children for better and early management The effect of shatyadi churna and tulasi patra churna will be compared in the management of Pratishyaya in age group of 6 to 12 years Both the churna anupana are ghruta with gudh and mishri respectively given in the diagnosed child for 7 days and follow up will be done every third fifth and seventh day 45 patients in each group will be studied and outcome of study will be assessed as per selected parameters of Pratishyaya |