| CTRI Number |
CTRI/2024/11/077250 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| 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 YAVANI CHURNA IN PURISHAJ KRIMI |
|
Scientific Title of Study
|
OPEN RANDOMIZED CONTROL CLINICAL TRIAL OF YAVANI CHURNA IN PURISHAJ KRIMI IN CHILDREN WITH SPECIAL REFERENCE of ASCARIS LUMBRICOIDES |
| 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 Shilpa Bodake |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli
Maharashtra
416301
India
Sangli
MAHARASHTRA
416301
India |
| Phone |
7030307753 |
| Fax |
|
| Email |
shilpabodake97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nareshkumar Babar |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
4th 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
Sangli
MAHARASHTRA
416301
India |
| Phone |
7507595454 |
| Fax |
|
| Email |
dr.nareshbabar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nareshkumar Babar |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
4th 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
Sangli
MAHARASHTRA
416301
India |
| Phone |
7507595454 |
| Fax |
|
| Email |
dr.nareshbabar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Shilpa Bodake |
| Address |
OPD No. 5 Balrog OPD Dhanvantari Ayurved Hospital Ashta |
| 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 Shilpa Bodake |
Dr Shilpa Bodake |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital
Sangli
MAHARASHTRA |
7030307753
shilpabodake97@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 Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B830||Visceral larva migrans. Ayurveda Condition: Krimi, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavani Churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidanga churna, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 Ayurvedic text like vaivarnya kshudamandya Gudkandu Udarshool Atisara
2 Patients selected irrespective of socio economic status
3 Dignosed cases of ascariasis |
|
| ExclusionCriteria |
| Details |
1 History of Allergic to Medicine
2 Acute symptoms like acute abdominal pain severe diarrheoa severe vomiting high grade fever
3 Any Congenital gastrointestinal anamolies like interstinal obstruction |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yavani churna is effective in the management of purishaj krimi |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vidang churna is effective in the management of purishaj krimi |
4 Weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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
|
Today life we live luxurious lifestyle which leads to many health problems. Helminthic infestation is the most common manifestation seen especially in children. Etiological factors related to food and daily routine for krimiroga has been described by sushruta. In aahar sambandhi nidan ( Food related ) includes curd, milk, jiggery, fish, meat, sesame, sweet and cold food products that causes kapha utklesham and vihar sambandhi nidan include divaswapna (day sleep). Adult ascaris lumbricoides are asymptomatic if infection is not so heavy, General symptoms such as abdominal pain, diarrhea, abdominal distension, sleeplessness,irritability,bruxism,loss of weight. There are many treatment, formulations about krimi mationed in ayurveda. Here I will study the effect of Yavani churna in management of krimi. Yavani churna is deepaniya, pachniya it increases apetite also it is kaphavata shamak and krimighna. So here i will give Yavani churna for 14th days and chack stool routine and microscopic examination before and after treatment.
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