| CTRI Number |
CTRI/2025/02/080059 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the effect of renogrit in protecting kidneys from side effects of cisplatin in patients with advanced cancers. |
|
Scientific Title of Study
|
A randomized clinical trial to assess the nephroprotective efficacy of renogrit in patients receiving Cisplatin based chemotherapy in advanced or metastatic solid tumors. |
| 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 Vikram Gota |
| Designation |
Professor and OIC- Department of Clinical Pharmacology |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
KS 102, ACTREC, TMC, Sector 22, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227405493 |
| Fax |
|
| Email |
vikramgota@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Gota |
| Designation |
Professor and OIC- Department of Clinical Pharmacology |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
KS 102, ACTREC, TMC, Sector 22, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227405493 |
| Fax |
|
| Email |
vikramgota@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Gota |
| Designation |
Professor and OIC- Department of Clinical Pharmacology |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
KS 102, ACTREC, TMC, Sector 22, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227405493 |
| Fax |
|
| Email |
vikramgota@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Institute (Divya Pharmacy)
Divya Pharmacy Unit II Khasra no. 210,211, Patanjali Food and Herbal Park, Padhartha, Laksar Road, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali research institute (Divya Pharmacy) |
| Address |
Divya Pharmacy Unit II Khasra no. 210,211, Patanjali Food and Herbal Park, Padhartha, Laksar Road, Haridwar |
| Type of Sponsor |
Research institution |
|
|
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 Vikram Gota |
ACTREC |
KS 102, ACTREC,TMC, Sector 22, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
02227405493
vikramgota@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C39||Malignant neoplasm of other and ill-defined sites in the respiratory system and intrathoracic organs. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Cisplatin | Dosage forms- Patients planned for administering cisplatin less than or equal to 75mg per m2.
Route of administration- Intravenous
Duration- Chemotherapy cycle as advised by the treating doctor. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Renogrit, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with evaluable disease, histologically documented confirmed diagnosis of solid malignancy of head and neck, lung and esophagus.
2. All patients planned for single agent cisplatin or its combination based chemotherapy at dose more than or equal to 75 mg/m2
3. ECOG performance status less than equal to 2
4. Patients who are administered only a full dose of cisplatin that is more than or equal to 75mg/m2.
5. Voluntarily signed informed consent.
6. Patient is ablee to swallow oral medication. |
|
| ExclusionCriteria |
| Details |
1. Diagnosis of chronic kidney disease (CKD) at baseline (glomerular filtration rate less than 60 mL/min/1.73m2 determined by Cockcorft-gault equation.
2. Past kidney transplant patients.
3. Previous use of any nephrotoxic drugs (e.g. aminoglycoside antibiotics, NSAIDs and any other drug which is potentially nephrotoxic including complementary alternative medicines) in the two weeks prior to initiation of Cisplatin (CisP) treatment.
4. Previous hematopoietic stem cell transplant
5. Any chronic or acute health condition that the investigator feels would render the patient inappropriate for this study, including but not limited to significant uncontrolled cardiorespiratory, hepatic, infectious, or renal disease at the discretion of the investigator
6. History hypersensitivity reaction (anaphylaxis, angioedema, exfoliated skin conditions).
7. Patients who receive fractionated dose of cisplatin will not be included in the study.
8. Patients requiring dose modification of cisplatin for any underlying condition.
9. Previous use of Cisplatin (CisP) based chemotherapy |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the efficacy of Renogrit in the prevention of cisplatin induced nephrotoxicity |
Baseline, Cycle 1 Day 1 and 1 year after chemotherapy treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To demonstrate the efficacy of Renogrit over standard supportive care in preventing deterioration of
markers of kidney function (eGFR and serum NGAL)
2. To demonstrate the efficacy of Renogrit in delaying the time to Acute Kidney Injury over standard
supportive care
3. To investigate the Incidence of proteinuria and electrolyte abnormalities (Mg/Ca) in the two arms
4. To demonstrate the efficacy of Renogrit over standard supportive care in decreasing the cumulative
incidence of treatment interruptions
5. To evaluate the difference in EFS between the two arms
6. To demonstrate the efficacy of Renogrit over standard supportive care in improving overall quality of
life (QoL)
7. To evaluate difference in pharmacokinetic profile of cisplatin between the two arms
8. To determine the incidence of treatment emergent adverse events (TEAE) |
Baseline, Cycle 1 Day 1 and 1 year after chemotherapy treatment. |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Chemotherapy is an integral part of cancer treatment. Cisplatin is one of the most effective chemotherapeutic agents, widely used for the treatment of several malignant solid tumors. However, its clinical use is limited due to the severe side effects, including nephrotoxicity and acute kidney injury. This study will help to determine whether the addition of renogrit to cisplatin-based chemotherapy will reduce the nephrotoxicity and improve quality of life. The study will be done in 2 cancer types namely head and neck cancer and lung cancer, as these are commonly treated with cisplatin-based chemotherapy. The study is based on the clinical experience of several ayurvedic practitioners all over India who have used Renogrit for renal disorders, chronic kidney disease, and it also supports and maintains renal health. A total of 220 participants will be enrolled for this study for a period of 2 years which aims to compare the nephroprotective effect in the presence and absence of renogrit. It is an interventional study with 50% patients on standard arm receiving cisplatin based chemotherapy and another 50% patients on interventionl arm receiving cisplatin based chemotherapy with renogrit tablets. This study involved PK bloos sampling at specified time points. FACT-G quality of life questionnaire will be administered to patients on both arms. |