| CTRI Number |
CTRI/2024/08/072245 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Ayurvedic Management in improving the Quality of Life in Stage 4 cancer During Chemotherapy |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study to Evaluate the Efficacy of Khadirarishta and Chandraprabha vati as an Adjuvant in Improving Quality of Life of Subjects Udergoing Chemotherapy in Stage 4 Cancer |
| 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 Mahantagouda Shivanna Sasanoor |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru Karnataka India
Mysore
KARNATAKA
570028
India |
| Phone |
8971810174 |
| Fax |
08212548360 |
| Email |
mahantsasanoor74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Beena M D |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa OPD 3 JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9538367282 |
| Fax |
08212548360 |
| Email |
drpbsreddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beena M D |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru |
| Address |
Department of Kayachikitsa OPD 3 JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9538367282 |
| Fax |
08212548360 |
| Email |
drpbsreddy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru - 570028 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Mahantagouda S |
| Address |
OPD 3 Department of Kayachikitsa JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru Karnataka India 570028 |
| 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 Mahantagouda Shivanna Sasanoor |
JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru |
Department Of Kayachikitsa OPD 3 JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru
Mysore
KARNATAKA |
8971810174
mahantsasanoor74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee - Human |
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 | Classical | | (1) Medicine Name: Khadirarishta, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: -(2) Medicine Name: Chandraprabha vati, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Of Care | Medicines given as prescribed by the Oncologist based on symptoms like Tab PAN 40mg orally once a day,Tab ONDEM orally once/twice a daily,Tab Folvite 5mg orally once a day, Tab Acetaminophen orally sos.Syp DUPHALAC 30ml orally HS etc.. for 3-5 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects above 18 years of age, irrespective of gender, religion, socio- economic status, type and site of the cancer.
2)Who are undergoing chemotherapy in stage 4 cancer.
3)Subjects who are undergone 1or more cycles of chemotherapy.
|
|
| ExclusionCriteria |
| Details |
1)Who Are Not Able To Take Oral Medicines
2)Terminally Ill Patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improve The Quality Of Life |
Every 15 days for 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Karnofsky scale
Improve in Quality of Life |
Assessment will be at every 15 days till 90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="1"
Months="5"
Days="30" |
|
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
|
A neoplasm or tumor is defined as a mass of tissue formed as a result of abnormal, excessive, uncoordinated, autonomous and purposeless proliferation of cells, even after removal of growth stimulus which caused It is the most dreadful, grave and tissue invasive disease which gradually hampers the quality of life, and decreases life expectancy and it is the second leading cause of death worldwide. The estimated number of incident cases of cancer in India for the year 2022 was found to be 14,61,427 (crude rate:100.4 per 100,000). In India, one in nine people are likely to develop cancer in his/her lifetime. Lung and breast cancers were the leading sites of cancer in males and females, respectively. Among the childhood (0-14 year) cancers, lymphoid leukemia (boys: 29.2% and girls: 24.2%) was the leading site. The incidence of cancer cases is estimated to increase by 12.8 per cent in 2025 as compared to 2020. By seeing the definition, signs and symptoms of cancer can be corelated with Arbuda and it is defined as swelling occurring in any part of the body due to vitiation of Tridosha, afflicting the Mamsa Dhatu, which is circular, fixed, slightly painful, big or wide spread, deep seated, slowly growing and non-suppurative. Chemotherapy is the sheet anchor of therapy used in surgical embryonal tumors and as primary treatment in advanced cancers not amenable to surgery or radiation. The care for terminally ill cancer patients includes control of symptoms, control of pain, treatment of psychological disturbances, maintenance of quality of life. The adverse effects due to chemotherapy remains at highest which includes anorexia, anaemia, nausea, hairloss, constipation, diarrhea, mood changes, easy bruising and infection, maximize their sufferings and deteriorates their quality of life. It is the need of hour to improve the quality of life of subjects undergoing chemotherapy. Khadirarishta and Chandraprabha Vati are two Ayurvedic formulations mentioned in Sharangadhara Samhita having direct indications in Arbuda, Gulma, Granthi, Pandu, Aruchi, agnimandya, Balya, Shoola, Pleehodara, Sarvarogahara with Rasayana effect can be administered to improve quality of life in subjects undergoing chemotherapy. In present study, an effort is put forth to evaluate the efficacy of Khadirarishta and Chandraprabha Vati as an adjuvant in improving quality of life of cancer subjects who are undergoing Chemotherapy in stage 4 cancer. |