| CTRI Number |
CTRI/2024/05/066800 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Duralabhadi Churna in vatik kasa(Dry cough)in children |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Duralabhadi Churna In The Management Of Vatik Kasa In Children. |
| 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 Rukhsana Sheikh |
| Designation |
MD Scholar |
| Affiliation |
Dr.D.Y.Patil College Of Ayurveda and Research Centre Pimpri Pune |
| Address |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8269347231 |
| Fax |
|
| Email |
rukhsanasheikh17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mosim Gafur Momin |
| Designation |
Associate Professor |
| Affiliation |
Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune |
| Address |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7350751503 |
| Fax |
|
| Email |
dr.mosim2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rukhsana Sheikh |
| Designation |
MD Scholar |
| Affiliation |
Dr.D.Y.Patil College Of Ayurveda and Research Centre Pimpri Pune |
| Address |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
08269347231 |
| Fax |
|
| Email |
rukhsanasheikh17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Rukhsana Sheikh |
| Address |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
| 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 Rukhsana Sheikh |
Dr.D.Y.Patil College Of Ayurveda and Research Centre Pimpri Pune 18 |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
08269347231
rukhsanasheikh17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH, (2) ICD-10 Condition:J00-J99||Diseases of the respiratory system. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Duralabhadi Curna, Reference: Yoga Ratnakara chapter-Balrogadhikar Shloka no.1 pg no.445, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Drug dose will be given by according to age |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)The patients having minimum 2 symptoms of Vatik Kasa are as follows-
1.The frequency of Kasa vega (Dry Cough)
2.Udarparshwa Shula (chest pain)
3.Swarbheda (Hoarseness of Voice)
4.Shukpurna Galasyata (Feeling Of Thorn Pricking in the Throat)
2) Patients between the ages of 1 year and 12 year.
3) The patients whose parents are ready to participate in the clinical trial by giving informed written consent.
|
|
| ExclusionCriteria |
| Details |
1)Patients of other types of kasa (pittaj, kaphaj,
kshayaj, kshataj)
2)Patients having life threatening illness and who is bed ridden.
3)Patients having any congenital respiratory and
GIT abnormality.
4)Patients who require surgical management. 5)Patients having concomitant other systemic disorders like T.B., Bronchiolitis, Asthma, Pneumonia, Bronchiectasis, Lung abscess, Foreign body, pertussis etc.
6)Patient having complaint of fever or recent history of fever .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in swarabheda & kasa vega after taking
Duralabhadi Churna in the management of Vatik Kasa.
|
5 Days study with followup on 3rd and 5th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the Adverse effect of Duralabhadi Churna, if any |
5 Days study with followup on 3rd and 5th day (0,3,5 Days) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
15/05/2024 |
| 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
|
This is a single arm clinical study in which the medicine Duralabhadi Churna will be given to 45 patients who have sign and symptoms of Vatik Kasa. The age group taken the study trial will be between 1 and 12 years old. Duralabhadi Churna with Madhu will be given for 5 days or three a day. Dose will be calculated by age formula. Follow-up will be done on the 3rd and 5th days of the case study, for a total duration of 5 days. The final conclusion will be drawn using statistical methods. |