| CTRI Number |
CTRI/2024/05/067186 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
approach to improve the Quality of Life of Cancer patients treated with Radiotherapy and Chemotherapy |
|
Scientific Title of Study
|
Integrative approach for improving the Quality of Life of Cancer patients treated with Radiotherapy and Chemotherapy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Gupta |
| Designation |
Associate Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
829912869 |
| Fax |
|
| Email |
drrashmiguptabhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmi Gupta |
| Designation |
Associate Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
829912869 |
| Fax |
|
| Email |
drrashmiguptabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Gupta |
| Designation |
Associate Professor |
| Affiliation |
IMS, BHU |
| Address |
Department of Shalya Tantra,
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
829912869 |
| Fax |
|
| Email |
drrashmiguptabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal hospital, Banaras Hindu University, Varanasi,221005, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Department of Shalya tantra Banaras Hindu University |
| Address |
Faculty of Ayurveda, Institute of Medical sciences, Banaras Hindu University,221005, Varanasi, Uttar Pradesh, India |
| 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 |
| drSatakshi Mishra |
Sir Sundar Lal Hospital, Institute of medical sciences, Banaras Hindu University |
Department of radiotherapy and radiation medicine, Room no.113 Institute of medical sciences BHU, Varanasi, Lanka 221005
Varanasi
UTTAR PRADESH |
8303059796
shatakshi.ald12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C50||Malignant neoplasm of breast. Ayurveda Condition: ARBUDAH, (2) ICD-10 Condition:C00-C14||Malignant neoplasms of lip, oral cavity and pharynx. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Ashwagandha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi, Reference: Guduchi, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Curcuma, Reference: Haridra, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 30(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm (Non Ayurveda) | | - | Placebo | No intervention | | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwgandha , Reference: Ashwagandha , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Weeks, anupAna/sahapAna: Yes(details: -Milk ), Additional Information: -for Head and Neck patient the duration of medicine will be 7 weeks and for Breast cancer patient it will be for 4 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven and newly diagnosed patients of Head & Neck and Breast cancer patients with no metastasis, ECOG performance scale 0-1, normal hematological, renal and hepatic parameters |
|
| ExclusionCriteria |
| Details |
previously treated for any cancer and on any other alternative medicine |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
Monthly till 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects |
Monthly till 6 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/05/2024 |
| 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="3"
Months="0"
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
|
This study is a randomized, open label, parallel group, single center trial, comparing the side effects and quality of life in Head and Neck cancer and Breast cancer patients who receive immune-modulator herbs and those who do not receive immune-modulator herbs following Radiotherapy and Chemotherapy for 6 months in 100 patients in Sir Sunderlal Hospital, Banaras Hindu University, India. The primary outcome is to assess the effects of immune-modulators on Quality of life in Head and neck and Breast cancer patients. |