| CTRI Number |
CTRI/2025/08/092804 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Check the Safety and Benefits of MVT Ayurvedic Tablets Along with Standard Chemotherapy in Women with Early-Stage Breast Cancer. |
|
Scientific Title of Study
|
A Prospective, Non-Randomised, Open-Label, Cohort Clinical Study to Evaluate the Safety
and Efficacy of Ayurvedic Formulation MVT Tablets in Combination with Standard
Chemotherapy in Female Patients with Stage 0–2 Invasive Breast Cancer. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SBRC_MVT_001_25 Final Version 01 dated 18 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Velavan |
| Designation |
oncologist |
| Affiliation |
Erode Cancer Centre |
| Address |
Department of Oncology,
Consultant room no.22, Ground floor, 1/393, Velavan nagar, Perundurai Road, Thindal
Consultant Room no. 22, Ground Floor
Erode
TAMIL NADU
638012
India |
| Phone |
09842334222 |
| Fax |
|
| Email |
kvels@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr.MS Ramasamy |
| Designation |
Head, Research and Development |
| Affiliation |
Sanjeev Biomedical Research Centre |
| Address |
Sanjeev Biomedical Research Centre
1/15, Kumaran Nagar, Keelkatalai,
Chennai-600117, Tamilnadu, India.
Chennai
TAMIL NADU
600117
India |
| Phone |
9176049309 |
| Fax |
|
| Email |
ramasamy.mani@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
D.K.Srinivasaprabhu |
| Designation |
Vice President -R&D |
| Affiliation |
Cholayil Private Limited |
| Address |
Cholayil Private Limited
R & D Centre, 31A/24, 4th Cross Main Road, SIDCO Industrial Estate, North Phase, Ambattur, Chennai – 600 098
Chennai
TAMIL NADU
600098
India |
| Phone |
044 43674100-199, 09003095775 |
| Fax |
|
| Email |
srinivasaprabhudk@cholayil.com |
|
|
Source of Monetary or Material Support
|
| Cholayil Private Limited
No. 8, J Block, 6th Avenue, Anna
Nagar (East), Chennai - 600 102
Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
D.K.Srinivasaprabhu |
| Address |
Cholayil Private Limited
No. 8, J Block, 6th Avenue, Anna
Nagar (East), Chennai - 600 102
Tamilnadu, India |
| 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 |
| DrKVelavan |
Erode Cancer Center |
Department of Oncology,
Consultant room no.22, Ground floor, 1/393, Velavan nagar, Perundurai Road, Thindal
Erode
TAMIL NADU |
9842334222
kvels@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Erode Cancer Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Treatment of female patients with Stage 0 to 2 invasive breast cancer who are receiving standard chemotherapy with Doxorubicin and Cyclophosphamide. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Treatment Arm A: Standard Treatment (Doxorubicin + Cyclophosphamide IV Injection)
|
- Doxorubicin injection at 60 mg/m², administered every 3 weeks as a 1-hour intravenous infusion.
- Cyclophosphamide injection at 600 mg/m², administered every 3 weeks as a 1-hour intravenous infusion.
- Total SOC cycles: 6 cycles (1 cycle = 3 weeks), over a total duration of approximately 18weeks.
- Patients may also receive supportive medications including morphine, opioids, or other symptom management drugs as required.
|
| Comparator Agent |
Treatment Arm B: Standard Treatment along with
Ayurvedic Formulation MVT Tablet |
-Doxorubicin injection at 60 mg/m², every 3 weeks as a 1-hour intravenous infusion.
- Cyclophosphamide injection at 600 mg/m², every 3 weeks as a 1-hour intravenous infusion.
- MVT oral tablets: Two tablets will be administered twice daily, once in the morning and once in the evening, after food, from Day 1 of the first cycle. The study drug will be dispensed at each visit from visit 2 to visit 7 in bottle(s) containing a sufficient number of tablets to last until the subsequent visit.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients aged between 18 and 65 years, with a pathologically confirmed diagnosis of invasive breast carcinoma
2. Patients with documented HER-2/Neu status, either negative or positive
3. Patients presenting with bi-dimensionally measurable and evaluable disease lesions
4. Patients showing no evidence of disease beyond the breast or chest wall, except for involvement of ipsilateral axillary lymph nodes
5. Patients with a life expectancy of at least 6 months at the time of screening
6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Patients with a chest CT scan at screening that shows no evidence of metastatic disease
8. Patients who are willing and able to provide written informed consent prior to study participation
9. Patients of childbearing potential who agree to use effective contraceptive methods throughout the study duration and for at least 3 months following its completion
10. Patients must have baseline laboratory values within the following acceptable ranges at screening: white blood cell count less than or equal to 3000/mm³ absolute neutrophil count less than or equal to 2000/mm³ hemoglobin concentration less than or equal to 8 g/dL, platelet count less than or equal to 100,000/mm³; serum creatinine greater than or equal to 1.5 times the upper normal limit (UNL), alkaline phosphatase greater than or equal to 1.5 × UNL; total serum bilirubin greater than or equal to 1.5 × the institutional UNL; serum glutamic-oxaloacetic transaminase (SGOT) less than or equal to 1.5 × UNL; and serum calcium within the institution-defined normal range
11. Patients with a negative pregnancy test result at the time of screening
|
|
| ExclusionCriteria |
| Details |
1. Patients with prior systemic treatment for breast cancer, including hormonal therapy, chemotherapy, or any other form of anticancer therapy
2. Patients who have received prior radiation therapy
3. Patients who have received, are currently receiving, or are scheduled to receive post-operative radiotherapy
4. Patients with a history of any malignancy other than breast cancer
5. Patients currently taking alternative therapies for cancer must discontinue such therapies prior to enrolment with appropriate washout period, alternative therapies are not permitted during either the treatment or follow-up phases of the study
6. Patients with peripheral neuropathy of Grade 2 or higher
7. Patients with electrocardiogram (ECG) findings that show significant abnormalities, as determined by the investigator
8. Patients who are medically unstable, including but not limited to those with active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, or superior vena cava syndrome. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Radiographic evaluation will be conducted as per the Response Evaluation Criteria in Solid Tumors (RECIST), which includes the following assessments,
a. Chest computed tomography (CT) imaging for evaluation of clinical lesions.
b. CT imaging for objective tumor response evaluation.
c. Tumor markers (HER2, CA15-3, CA27-29) and histological assessment.
2. Improvement in Quality of life (SF-36) comparing baseline with end of study. |
The radiographic evaluations will be conducted in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Visits 4, 6, and 8
-CT imaging
Time frame: visits 4,6, and 8
-Tumor markers (HER2, CA15-3, CA27-29)
Time Frame: Screening Visit (Visit 1), Week 6 (Visit 4), Week 12 (Visit 6), Week 18 (Visit 8).
and histological assessment at Screening Visit
2. Quality of life will be evaluated at two key time points
Time frame: baseline and end of study (EOS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. NCI (National Cancer Institute) toxicity criteria at every
course-adverse events were summarized by NCI CTC (Common Toxicity Criteria).
2. TEAEs will be graded and tabulated by severity and relationship to the study medications. |
(Time frame from baseline to EOS). |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 |
|
Date of First Enrollment (India)
|
31/08/2025 |
| 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="4"
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
|
The current study is designed to comprehensively evaluate the safety and efficacy of the Ayurvedic formulation MVT Tablets in female patients diagnosed with Stage 0–2 invasive breast cancer. The primary objectives include assessing the safety and tolerability of MVT Tablets when administered in combination with standard chemotherapy, and investigating its efficacy in terms of clinical response rate in the target population. This includes monitoring tumor regression, treatment-related adverse events, and overall therapeutic benefit. The secondary objectives aim to explore the herb–drug compatibility, understand potential immunemodulatory effects, and evaluate improvements in quality of life during chemotherapy. This trial utilizes a synergistic polyherbal composition, including Aegle marmelos (Bilwa) 300 mg, Ocimum sanctum (Tulasi) 100 mg, Curcuma longa (Haridra) 25 mg, Piper nigrum (Marica) 25 mg, and Tinospora cordifolia (Seenthil) 50 mg each selected for its traditionally recognized anticancer, anti-inflammatory, and immunomodulatory properties. By integrating these botanicals into standard cancer care, the study seeks to explore holistic, integrative approaches for managing breast cancer and improving patient outcomes. This ongoing study aims to provide foundational clinical data, bridging traditional knowledge with modern oncology, and paving the way for further development of integrated therapeutic strategies that align with patient-centered, personalized care in breast cancer treatment. |