| CTRI Number |
CTRI/2024/08/072669 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
The Effect Of Shunthyadi Yog In The Management Of Kaphaj Chhardi or vomiting In Children |
|
Scientific Title of Study
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Shunthyadi Yog In The Management Of Kaphaj Chhardi 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 |
SHEETAL SURESH SONWANE |
| Designation |
BAMS,MD SCHOLAR Kaumarbhritya |
| Affiliation |
CSMSS AYURVED COLLEGE |
| Address |
OPD No. 14 , CSMSS Ayurved college , Kaumarbhritya department ,Paithan road , Kanchanwadi , Sambhajinagar
KANCHANWADI , SAMBHAGINAGAR
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9511795134 |
| Fax |
|
| Email |
sheetal2796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAVITA FADNAVIS |
| Designation |
BAMS,MD ASSOCIATE PROFESSOR AND PG GUIDE |
| Affiliation |
CSMSS AYURVED COLLEGE |
| Address |
OPD No. 14 , CSMSS Ayurved college , Kaumarbhritya department, Paithan road , kanchanwadi
KANCHANWADI , SAMBHAGINAGAR
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHEETAL SURESH SONWANE |
| Designation |
BAMS,MD SCHOLAR |
| Affiliation |
CSMSS AYURVED COLLEGE |
| Address |
OPD NO. 14 , Kaumarbhritya department , CSMSS Ayurved college , Kanchanwadi
KANCHANWADI , SAMBHAGINAGAR
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9511795134 |
| Fax |
|
| Email |
sheetal2796@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS AYURVED COLLEGE , KANCHANWADI , PAITHAN ROAD , AURANGABAD , MAHARASHTRA , INDIA 431002 |
|
|
Primary Sponsor
|
| Name |
SHEETAL SONWANE |
| Address |
CSMSS AYURVED COLLGE , KANCHANWADI , PAITHAN ROAD , SAMBHAJINAGAR |
| 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 SHEETAL SURESH SONWANE |
CSMSS AYURVED COLLEGE |
OPD NO. 14 , Balrog deartment , CSMSS AYURVED COLLEGE , Kaumarbhritya department . KANCHANWADI
Aurangabad
MAHARASHTRA |
9511795134
sheetal2796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Commitee CHHATRAPATI SHAHU MAHARAJ SHIKSHAN SANSTHA AYURVED MAHAVIDYALAYA AND RUGNALAYA , JANCHANWADI , AURANGABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: CARDIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: HARITAKI CHOORNA , Reference: BHAISHJYA RATNAWALI, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.5(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi yog , Reference: bhavprakash madhyam khand , Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.5(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: Yes(details: Madhu ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 2 to 6 years.
2) Patients irrespective of their gender, religion and socio economic class.
3) Patients having sign & symptoms of Kaphaj Chhardi as mentioned in Ayurvedic text.
|
|
| ExclusionCriteria |
| Details |
1)Patients below 2 years and above 6 years of age.
2) Case of Chhardi other than Kaphaj.
3) Patient suffering from Chhardi as upadravatmaka symptom.
4) Patients of known anatomical defects and systemic illness.
5) Patients having severe dehydration due to Chhardi and Chhardi associated with diarrhea.
6) All surgical cases.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRILLASA , ARUCHI , CHHARDI VEG DECREASES TO GRADE 0 |
BASELINE , 3RD AND 5TH DAY OF STARTING TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NO DEHYDRATION |
5 TH 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 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="0"
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
|
Randomized Controlled Clinical Study To Evaluate The Efficacy Of Shunthyadi Yog In The Management Of Kaphaj Chhardi In Children Rationale of study : Chhardi is a disease of common concern in the pediatric age group. The conventional treatment in modern medicine has side effects. Metachloperamide and Prochlorperazine should not be used in children due to the high risk of extrapyramidal reaction and symptoms respectively ,while antihistamine should be avoided due to sedation. Vomiting can occur as a symptom, complication or as disease. When it occurs,parents want it to be stopped as soon as possible so in order to provide relief with no side effects Ayurvedic medicines are found to be useful.
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