| CTRI Number |
CTRI/2020/07/026593 [Registered on: 15/07/2020] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Chemotherapy associated Anemia through Nagaphani fruit |
|
Scientific Title of Study
|
Pharmaco-therapeutic evaluation of Nagaphani( Opuntia elatior Mill.) fruit in Pandu with special reference to its efficacy in Cancer and Chemotherapy associated Anemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharada Ramesh |
| Designation |
Ph D scholar |
| Affiliation |
Institute of Post Graduate Teaching and Research in Ayurveda |
| Address |
Jamnagar
Department of Dravyaguna 3rd floor IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9620554829 |
| Fax |
|
| Email |
dr.shaaradaramesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rabinarayan Acharya |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Post Graduate Teaching and Research in Ayurveda |
| Address |
Room no 329 Institute of Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
Department of Dravyaguna 3rd floor IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9924585855 |
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rabinarayan Acharya |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Post Graduate Teaching and Research in Ayurveda |
| Address |
Room no 329 Institute of Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
Department of Dravyaguna 3rd floor IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9924585855 |
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Teaching and Research in Ayurveda GAU Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute of Post Graduate Teaching and Research in Ayurveda GAU Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sharada Ramesh |
PG Ayurveda Hospital |
OPD no 10 Institute of Post Graduate Teaching and Research in Ayurveda GAU Jamnagar
Jamnagar
GUJARAT |
9620554829
dr.shaaradaramesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D648||Other specified anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
In Group A Nagaphani Phala Swarasa( fruit juice) |
In Group A Nagaphani Phala Swarasa( fruit juice) 40ml/day in two divided before meal for the duration of 60 days will be given orally |
| Comparator Agent |
In Group B conventional treatment of Chemotherapy associated Anemia |
In Group B conventional treatment of Chemotherapy associated Anemia will be given for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Any type of Cancer patients under Chemotherapy associated with Anemia
Hb% below 12gm for female and below 13gm for male or reduced RBC count
|
|
| ExclusionCriteria |
| Details |
Patient who are not under Chemotherapy
Pregnancy and Lactation
Severe Renal/Hepatic/Cardiac disease
Any continuing blood loss
Hemoglobin percentage below 6gm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Hb percentage |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased RBC count |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2020 |
| Date of Study Completion (India) |
22/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An open labeled randomized controlled clinical trial will be carried out to assess the efficacy of Nagaphani (Opuntia elatior Mill.) fruit juice in chemotherapy associated Anemia on a minimum of 30 patients in the dose of 40 ml per day orally before meal in two divided doses for a duration of 60 days and followup of 30 days will be carried out along with conventional treatment protocol and compared with conventional group |