| CTRI Number |
CTRI/2023/07/055417 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ayurveda oral medicine as an add-on therapy in lung cancer |
|
Scientific Title of Study
|
An Open-label,two-arm, Exploratory Randomised Controlled Trial to evaluate the effect of Vardhamana Pippali Rasayana as an add-on therapy in the management of Non-small cell lung 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 Rambha Pandey |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Dept. of Radiation Oncology, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9310012026 |
| Fax |
|
| Email |
dr.rambhapandey.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V G Huddar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Dept. of Kayachikitsa, All India Institute of Ayurveda, Mathura Road, Gautampuri, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9986697942 |
| Fax |
|
| Email |
drvghuddar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvathy Venate |
| Designation |
PhD scholar |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Dept. of Kayachikitsa, All India Institute of Ayurveda, Sarita Vihar
New Delhi
DELHI
110076
India |
| Phone |
8086875019 |
| Fax |
|
| Email |
93parvati@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, MATHURA ROAD, GAUTAMPURI, SARITA VIHAR, DELHI-110076 |
| 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 |
| DR RAMBHA PANDEY |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
DEPT. OF RADIATION ONCOLOGY OPD, BRAIRCH, AIIMS- NEW DELHI
New Delhi
DELHI |
9310012026
dr.rambhapandey.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
| INSTITUTIONAL ETHICAL COMMITTEE All INDIA INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C349||Malignant neoplasm of unspecifiedpart of bronchus or lung. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vardhamana Pippali Rasayana, Reference: Charaka Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 19 Days, anupAna/sahapAna: Yes(details: Cow milk), Additional Information: -(2) Medicine Name: Trivrut lehyam, Reference: Astanga Hridaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 25(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Cow milk), Additional Information: For Virechana after Vardhamana Pippali Rasayana on day 20(3) Medicine Name: Pippali Rasayana, Reference: Charaka Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 70 Days, anupAna/sahapAna: Yes(details: cow milk), Additional Information: As samana dose during the entire course of first line of management | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard of Care | Stagewise chart has been enclosed |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of histologically proven lung malignancy (NSCLC of any subtype), willing to participate in the study
2. Patients with ECOG PS 0-III
3. Patients suffering from non-small cell lung cancer- Stage I to IV B and treatment naïve at the time of screening
4. Age- 18-75 years of age
5. Gender- both male and female (non-pregnant, non-lactating)
6. Patients with no diagnosis of cancer within the past one year
|
|
| ExclusionCriteria |
| Details |
- Patients not willing to take part in the study
- Unable to take oral medications especially in the form of powder.
- Patients of ECOG PS IV, V
- Patients with active peptic ulcer, dyspepsia, or bleeding per rectum
- Significant cardiovascular disease, such as myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
-Inability to comply with other requirements of the protocol
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Objective Response Rate assessed through changes in the PET CT scan reports prior to & after intervention according to PET Response Criteria in Solid Tumors (PERCIST,Version 1.0).
-Changes in the clinical symptoms of the patients before & after treatment using EORTC- LC13 questionnaire.
|
WEEK-1 WEEK 4 WEEK8 WEEK 12
WEEK 16 WEEK 20 WEEK 24
WEEK 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Changes in the Quality of Life of the patients before & after treatment using EORTC-QLQ- C30 questionnaire.
-Changes in the lung functions by means of Spirometry.
-The safety profile of the intervention will be assessed by comparing
-Hemogram, LFT & RFT parameters before & after intervention.
-Number of participants with specified adverse event that is grade 2 or above & related to treatment. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5)
|
WEEK-1 WEEK 4 WEEK8 WEEK 12
WEEK 16 WEEK 20 WEEK 24
WEEK 28 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/07/2023 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [93parvati@gmail.com].
- For how long will this data be available start date provided 06-10-2026 and end date provided 06-10-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Lung cancer, with increasing incidence and disproportionately
high mortality remains a major health hazard to the Indian population. Majority
of the patients present at the advanced stages of the disease with narrow
curative options. Majority belong to the low socio-economic strata of the
society and hence unable to reap the benefits of advanced therapeutic
techniques and biologics. With disease progression occurring less than a year
post-diagnosis, there is need for urgent intervention that is effective as well
as economically feasible. Quality of life is an important clinical indicator of
disease control for the patient.
Traditional systems of medicine like Ayurveda are sought
after by the cancer patients for reduced side-effect profile and improved
quality of life. Dhehghan et al reported a significantly high QoL among CAM
using terminally ill cancer patients.
The study drug, Vardhamana Pippali Rasayana is widely practiced in treating the
symptoms of cough, dyspnea and anorexia among lung cancer patients to good
results. However, there are no clinical evidences generated so far. This study is expected to improve the treatment outcomes of lung
cancer in terms of symptomatic relief and enhance quality of life of the
patient without causing major side-effects. Moreover, based on the previous
in-vitro and in-vivo studies, there may be better tumor response to the add-on
intervention.
|