| CTRI Number |
CTRI/2024/07/070861 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study to show the efficacy of Triphadi ghrita and Albendazole in the management of intestinal worms in children. |
|
Scientific Title of Study
|
A comparative clinical trial to study the effect of Triphaladi ghrita and albendazole in the management of Krimi roga 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 |
Puja Kumari |
| Designation |
MD scholar(Ayu.) |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of kaumarbhritya
Government Ayurvedic College and Hospital,
Landmark- Buddha Murti Kadamkuan Patna
Department of Kaumarbhritya
Patna 800003
Patna
BIHAR
800003
India |
| Phone |
7631504161 |
| Fax |
- |
| Email |
Pujabgp011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArvind Chaurasia |
| Designation |
Prof.& HOD Department of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College, Kadamkuan |
| Address |
Department of kaumarbhritya
Government Ayurvedic College and Hospital ,
Landmark - Buddha Murti Kadamkuan Patna
Government Ayurvedic College and Hospital
Patna 800003
Patna
BIHAR
800003
India |
| Phone |
7631504161 |
| Fax |
- |
| Email |
arvindschaurasia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpy Gupta |
| Designation |
Assistant Professor Department of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College ,Kadamkuan |
| Address |
Department of kaumarbhritya
Government Ayurvedic College and Hospital,
Landmark- Buddha Murti Kadamkuan Patna
Government Ayurvedic College and Hospital,
Patna 800003
Patna
BIHAR
800003
India |
| Phone |
7631504161 |
| Fax |
- |
| Email |
drguptashilpy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan , Patna-800003, Bihar , India |
|
|
Primary Sponsor
|
| Name |
Dr Puja Kumari |
| Address |
MD Scholar
Department of kaumarbhritya
Government Ayurvedic College and Hospital, Kadamkuan,Patna-800003,Bihar,India |
| 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 Puja Kumari |
Government Ayurvedic College and Hospital |
Department of Kaumarbhritya, OPD No.5, Kadamkuan Near Buddha murti, Patna-800003,
Patna
BIHAR |
7631504161
Pujabgp011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurvedic College And Hospital Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B80||Enterobiasis. Ayurveda Condition: KRUMIH/SANJATAKRUMI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi ghrita, Reference: Bhaishajya Ratnavali Krimiroga, Route: Oral, Dosage Form: Ghrita, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Lukewarm milk/water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi ghrita, Reference: Bhaishajya Ratnavali Krimiroga, Route: Oral, Dosage Form: Ghrita, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Lukewarm milk/water), Additional Information: In this intervention arm Albendazole 400 mg tablet will also given in addition to Triphaladi ghrita to the patients. | | 3 | Comparator Arm (Non Ayurveda) | | - | Albendazole tablet | Route- oral. Dosage form -Tablet, Dose- 400mg, Albendazole will be given to patients for 15 days. Dose- 1 tab in a week on 0 day, 7th day, 14th day. |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sign and symptoms of krimi roga.
Age 3 to 12 years. |
|
| ExclusionCriteria |
| Details |
Patients not willing for trial.
Patients affected with any systemic disease.
Patients on any other medication.
Age more than 12 years and less than 3 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign and symptoms will be assessed before and after treatment. Those are teeth grinding, anal itching,pain abdomen,anorexia,patchy apperance on face |
at 0day, 15th day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stool test before & after treatment for examination of worms, its cyst & ova. |
Group A- 14 days
Group B- 14 days
Group C- 14 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)
|
15/08/2024 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pujabgp011@gmail.com].
- For how long will this data be available start date provided 25-04-2025 and end date provided 25-04-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is a randomised, open, intervantional prospective trial comparing the effect of Triphaladi Grita and Albendazole in the management of krimi Roga in Children. The clinical study will be conducted on patients attending OPD and IPD of Government Ayurvedic College and Hospital, Patna, Bihar. Patients will be treated in 3 groups. GROUP A- 30 patients will be treated with Triphaladi Grita for 15 days. BD with lukewarm milk. or lukewarm water GROUP B- 30 patients will be treated with Albendazole for 15 days. Dose 1 tab in a week with lukewarm water i.e. on 0 day, 7th day and 14th day GROUP C- 30 patients will be treated with both Triphaladi Grita and Albendazole. Dose of Triphaladi Grita will be according to age of patients for 15 days BD with lukewarm milk. Dose of Albendazole will be 1 tab in a week for 15 days AGE - Patients between 3-12 years of age will be selected for study. |