| CTRI Number |
CTRI/2025/05/087504 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of syrup paribhadra in krimi |
|
Scientific Title of Study
|
A comparative clinical study of syrup paribhadra and vidangkrishnadi kashayam in management of purishaj krimi w.s.r.intestinal nematodes |
| 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 Diksha Sharma |
| Designation |
PG scholar |
| Affiliation |
Rani dullaiya smriti ayurvedic pg college and hospital Bhopal MP |
| Address |
OPD no 4 Kaumarbhrtiya department rani Dullaiya smriti ayurvedic pg college and hospital Bhopal MP
Rani Dullaiya smriti ayurved PG college and hospital Bhopal MP
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9713095954 |
| Fax |
|
| Email |
drdikshaujjain954@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Dhaybar |
| Designation |
Head of Department of Kaumarbhrtiya professor |
| Affiliation |
Rani dullaiya smriti ayurvedic pg college and hospital Bhopal MP |
| Address |
OPD no 4 Kaumarbhrtiya department rani Dullaiya smriti ayurvedic pg college and hospital Bhopal MP
OPD no 4 Kaumarbhrtiya department Rani Dullaiya smriti ayurved PG college and hospital Bhopal MP
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9960759080 |
| Fax |
|
| Email |
vd.umd11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Sharma |
| Designation |
PG scholar |
| Affiliation |
Rani dullaiya smriti ayurvedic pg college and hospital Bhopal MP |
| Address |
OPD no 4 Kaumarbhrtiya department Rani Dullaiya smriti ayurvedic pg college and hospital Bhopal MP
OPD no 4 Kaumarbhrtiya department Rani Dullaiya smriti ayurved PG college and hospital Bhopal MP
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9713095954 |
| Fax |
|
| Email |
drdikshaujjain954@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya smriti ayurved PG college and hospital Bhopal MP 462044 |
|
|
Primary Sponsor
|
| Name |
Dr Diksha Sharma |
| Address |
OPD no 4 Kaumarbhrtiya department Rani Dullaiya smriti ayurvedic pg college and hospital Bhopal MP |
| 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 Diksha Sharma |
Rani Dullaiya Smriti Ayurved Hospital Bhopal |
OPD no 4 Kaumarbhrtiya Department Rani Dullaiya Smriti ayurved PG college and hospital Barkhedi kalan bhadbhada road Bhopal MP
Bhopal
MADHYA PRADESH |
09713095954
drdikshaujjain954@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Rani Dullaiya smriti ayurved PG college and hospital Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B818||Other specified intestinal helminthiases. Ayurveda Condition: PURISHAJAKRUMIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Paribhadra , Reference: Chakradutta , Route: Oral, Dosage Form: Swaras/ Juice, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidangkrishnadi kashayam , Reference: Sahtrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children whose parent’s give informed consent.
The patients having classical symptoms of purishajkrimi , bhaktodwesh, udarshool, gudakandu, atisar, vivarnata will be select.
Children within age group of 5-12year’s.
|
|
| ExclusionCriteria |
| Details |
Patient below age 5 and above 12 years.
Patient having complaints of severe systemic illness will be excluded from the study
Patient having discontinuation of treatment or follow-up.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trail medicine is assessed for the management of purishaj krimi wsr intestinal nematods |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trail drug is assessed for bhaktodwedh,gudkandu,atisar, udarshool & classical symptoms of purishaj krimi will completely subside |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/06/2025 |
| 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="4"
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
|
Many children in India are suffering from worms, so providing such medicines to children is cheap and easily palative and no edverse effect. And complete care of worm infestation by deworming through ayurveda such as syrup paribhadra and vidangkrishnadi kashayam. |