| CTRI Number |
CTRI/2024/10/075507 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| 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 Comparative Effects of two drugs Kasantak Churna and Haritakyadi Gutika in Children of age 6 to 12 years having cough disease. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Kasantak Churna and Haritakyadi Gutika in the Management of Kaphaja 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 |
Sfurti P Bansod |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College, Nagpur 440024 |
| Address |
PDEAS College Of Ayurved And Research Centre , Department OF kAUMARBHRITYA ,Nigdi Pune 411044 Maharashtra
India
Nagpur
MAHARASHTRA
411044
India |
| Phone |
9226262735 |
| Fax |
|
| Email |
drsfurti@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi S Deodas |
| Designation |
Professor HOD PhD Guide |
| Affiliation |
PDEAS College Of Ayurved And Research Centre |
| Address |
PDEAS College Of Ayurveda and Research Centre Department Of KAUMARBHRITYA Nigadi Pune 411044 Maharashtra
India
PDEAS College Of Ayurved And Research Centre Department Of Kaumarbhritya Nigdi Pune 411044 Maharashtra
India
Nagpur
MAHARASHTRA
411044
India |
| Phone |
9423010818 |
| Fax |
|
| Email |
drdeodasms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sfurti P Bansod |
| Designation |
PhD Scholar |
| Affiliation |
Government Ayurved College, Nagpur 440024 |
| Address |
PDEAS College Of Ayurved And Research Centre , Department OF kAUMARBHRITYA ,Nigdi Pune 411044 Maharashtra
India
Nagpur
MAHARASHTRA
411044
India |
| Phone |
9226262735 |
| Fax |
|
| Email |
drsfurti@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College Of Ayurved And Research Centre Nigdi Pune 410044 Maharashtra |
|
|
Primary Sponsor
|
| Name |
PDEAS College Of Ayurved And Research Centre Nigdi Pune 410044 Maharashtra |
| Address |
Department Of Kaumarbhritya, Nigdi Pune 410044 |
| Type of Sponsor |
Other [PDEAS College Of Ayurved And Research Centre Nigdi Pune 410044 Maharashtra] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Government Ayurved College Nagpur |
Raje Raghuji Nagar, Sakkardara Chowk, Nagpur 440024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sfurti P Bansod |
Government Ayurved College, Raje Raghuji Nagar, Nagpur 440024 |
Raje Raghuji Nagar, Sakkardara Chowk, Nagpur 440024
Nagpur
MAHARASHTRA |
9226262735
drsfurti@rediffmail.com |
| Dr Sfurti P Bansod |
PDEAS College Of Ayurved And Research Centre ,Nigdi Pune |
PDEAS College Of Ayurved And Research Centre, Department of Kaumarbhritya ,Nigdi Pune 411044
Pune
MAHARASHTRA |
9226262735
drsfurti@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE REPORT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Gutika, Reference: Chakradatta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: - Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kasantak Churna, Reference: Bhaishajya Ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: - Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) patients of either gender, irrespective of religion and socio-economic status of age between 6 to 12 years.
2)Patient having any of the following two or more signs and symptoms of Kaphaja Kasa described in the text -
KASA (COUGH) SEVERITY, NUMBER OF BOUTS OF COUGH,DURATION OF EACH BOUT OF COUGH, KAPHASAMPOORNAURA,NISHTHEEVAN (SPUTUM), PEENAS(CORYZA),UTKLESH(NAUSEA),DISTURBANCE IN SLEEP,(SWARBHEDA)HOARSENESS OF VOICE, CHHARDI (VOMITTING),(KANTHA KANDU)THROAT ITCHING/ IRRITATION,(MANDAGNI)DECREASED DIGESTIVE FIRE AND (ARUCHI)ANOREXIA.
3) PATIENTS HAVING NO INFECTIVE PATHOLOGY.
4) PATIENTS READY TO GIVE CONSENT/ASSENT FOR PARTICIPATION IN THE STUDY. |
|
| ExclusionCriteria |
| Details |
1) PATIENTS OTHER THAN KAPHAJA KASA.
2) PATIENTS HAVINF COUGH (KASA) MORE THAN 2 WEEKS.
3) PATIENTS OF K/C/O COPDPNEUMONIA,BRONCHIAL ASTHAMA(TAMAK SHWASA, PULMONARY TUBERCULOSIS,CROUP SYNDROME,DIPHTHERIA,PERTUSIS,EMPHYSEMA WILL BE EXCLUDED FROM THE STUDY AFTER BEING DIAGNOSED CLINICALLY OR RADIOLOGICALLY(IN SUSPECTED PATIENTS ONLY.
3) PATIENTS WITH ANY OTHER MAJOR ILLNESS .
4)PATIENTS WITH ANY ANATOMICAL AND CONGENITAL ANOMOLIES.
5) PATIENTS WITH ACUTE PYREXIA MORE THAN 100F. |
|
|
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 |
| Relief from symptoms of Cough disease vomitting Disturbed Sleep Sore Throat Itching Hoarseness of voice after giving medicine for 7 days |
Relief from symptoms of Cough disease Vomitting Disturbed Sleep Sore Throat Itching Hoarseness of voice after giving medicine for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
comparision of the effects on the subjective
parameters between Two groups and follow-ups will be done and a comparison of the effect on objective parameters between two groups before and after the study will be done.
|
comparision of percentage of relief from symptoms of kaphaja kasa . |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
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 planned to evaluate and compare the efficacy of the Kasantak Churna with Madhu and Haritakyadi Gutika with Guda in the Kaphaja Kasa.100 patients of kaphaja Kasa from our hospital and periphery will be taken. They will be divided into two groups by the lottery method. The trial group will be administered Kasantak Churna with Madhu and the comparison group will be administered Haritakyadi Gutika with Guda into three divided doses in each group. Comparison of the effects on the subjective parameters between Two groups and follow-ups will be done and a comparison of the effect on objective parameters between two groups before and after the study will be done. Results, observations and conclusions will be drawn after statistical analysis. | |