| CTRI Number |
CTRI/2024/02/063254 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of qulity of life of cancer patient after receving Bio-bliss sryup |
|
Scientific Title of Study
|
Evauluating quality of life in cancer patients receiving BIO-BLISS THE SMART HEALTH ELIXIR as add on therapy-A single arm clinical study |
| 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 Aena V Pathak |
| Designation |
PhD scholar ,Assistant Professor Kayachikitsa |
| Affiliation |
J S Ayurveda Mahavidhyalaya college road Nadiad |
| Address |
J S Ayurveda Mahavidhayalya college road Nadiad 387001
Kheda
GUJARAT
387001
India |
| Phone |
8866858699 |
| Fax |
|
| Email |
aenapathak2094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aena V Pathak |
| Designation |
PhD scholar ,Assistant Professor Kayachikitsa Department |
| Affiliation |
J S Ayurveda Mahavidhyalaya college road Nadiad |
| Address |
J S Ayurveda Mahavidhayalya college road Nadiad 387001
GUJARAT
387001
India |
| Phone |
8866858699 |
| Fax |
|
| Email |
aenapathak2094@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aena V Pathak |
| Designation |
PhD scholar ,Assistant Professor Kayachikitsa Department |
| Affiliation |
J S Ayurveda Mahavidhyalaya college road Nadiad |
| Address |
J S Ayurveda Mahavidhayalya college road Nadiad 387001
GUJARAT
387001
India |
| Phone |
8866858699 |
| Fax |
|
| Email |
aenapathak2094@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
A for Ayurveda |
| Address |
shyamal cross road satellite road Ahmadabad Gujarat |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Aena Pathak |
P D Patel Ayurvedic Hospital |
P D Patel Ayurveda hospital and J S Ayurveda mahavidhyalaya college road Nadiad 387001
Kheda
GUJARAT |
8866858699
aenapathak2094@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee for human resarch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D499||Neoplasm of unspecified behavior of unspecified site. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: BIO BLISS HEALTH ELIXER, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both gender aged 18-70 years
dignosed patients of cancer of any origin in general
patients who had on going or not taking any treatment like chemotherapy and or radiation therapy |
|
| ExclusionCriteria |
| Details |
patients who are not willing to participate in the study
severely ill with many complication
Any other condition which may jeopardize the study
Any other condition in which the investigators opinion would preclude the subject from the participating |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the quality of life of cancer patients after the administration of bio-bliss sryup as an add on therapy |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate changes in quality of life in cancer patient WHO and FACT G questioner changes before and after administration of intervention |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/03/2024 |
| Date of Study Completion (India) |
05/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
From the present study, it can be concluded that the bio-bliss health elixir gives result in to improving the quality of life in all the domain of physical, social, emotional and functional wellbeing in cancer patients. This therapy certainly improves quality of life of the patient and may enhance the life expectancy. In a nutshell, BIOBLISS- THE SMART HEALTH ELIXIR as an add-on therapy has effective therapy in the quality of life of cancer patients |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present study is prospective and open labelled,single arm clinical study total duration of the study is 4 week and sample size is 30 to asses the changes the quality life of patients of cancer on the basis of WHO and FACT G after administration of BIO BLISS health elixer |