| CTRI Number |
CTRI/2021/01/030860 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
27/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TREATMENT TOXICITY OF ARBUDA |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF TREATMENT TOXICITY OF ARBUDA WITH SPECIAL REFERENCE TO PRAKRITI,KOSTHA,AGNI AND SATMYA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MEENA KUMARI |
| Designation |
JUNIOR RESIDENT III |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9783028290 |
| Fax |
|
| Email |
meenapooniabhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEENA KUMARI |
| Designation |
JUNIOR RESIDENT III |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9783028290 |
| Fax |
|
| Email |
meenapooniabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MEENA KUMARI |
| Designation |
JUNIOR RESIDENT III |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCE BHU VARANASI |
| Address |
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9783028290 |
| Fax |
|
| Email |
meenapooniabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University Varansi UP |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF VIKRITI VIGYAN |
| Address |
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI |
| Type of Sponsor |
Government 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 P S BYADGI |
Sir Sunderlal hospital BHU Varanasi, UP221005 |
DEPARTMENT OF VIKRITI VIGYAN FACULTY OF AYURVEDA IMS BHU VARANASI
Varanasi
UTTAR PRADESH |
9450711759
psbyadgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C23||Malignant neoplasm of gallbladder. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years
Patients with ECOG<2
Patients receiving chemotherapy for solid tumors |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Not willing to complete the consent process as describe in proforma.
Inability to comply with study procedures and methods. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WHO Toxicity criteria |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
.Registration of cancer patients.selection of the patients based on anticancer management mainly chemotherapy etc identification of kostha, prakriti, agni and Satmya assessment of adverse reactions in context to various prakriti, kostha, Agni and Satmya Final assessment of the datas will be analyzed after getting the complete dats |