| CTRI Number |
CTRI/2022/11/047416 [Registered on: 18/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary supplement] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the efficacy of Oral Disintegration Tablet (ODT), a dietary supplement containing polyherbal extracts in the management of Xerostomia in Head and Neck Cancer patients receiving radiation treatment |
|
Scientific Title of Study
|
A pilot study on the feasibility and efficacy of Oral Disintegration Tablet (ODT), containing polyherbal extracts, a dietary supplement in the management of Xerostomia in Head and Neck Cancer patients receiving radiation treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Harikrishnan MD Ayu |
| Designation |
Senior Research Fellow |
| Affiliation |
Heavenly Fuels pvt. Ltd |
| Address |
Room No.2, First floor
Research and Development wing
Heavenly Fuel Pvt Ltd,
Basant Nagar
Chennai
Chennai
TAMIL NADU
600090
India |
| Phone |
8939933150 |
| Fax |
|
| Email |
drhari@colouramalgamations.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Madhavan MD |
| Designation |
Associate Professor |
| Affiliation |
Cancer Institute [WIA] Adyar |
| Address |
Room No. 15
General OPD Radiation Oncology
S.K KRISHNAMURTHY CAMPUS
CANCER INSTITUTE [WIA]
GANDHI MANDAPAM ROAD
ADYAR, Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
8281796896 |
| Fax |
|
| Email |
drrammadhavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Harikrishnan MD Ayu |
| Designation |
Senior Research Fellow |
| Affiliation |
Heavenly Fuels pvt. Ltd |
| Address |
Room No.2, First Floor,
Research and Development wing,
Heavenly Fuel Pvt Ltd,
Basant Nagar
Chennai
Chennai
TAMIL NADU
600020
India |
| Phone |
8939933150 |
| Fax |
|
| Email |
drhari@colouramalgamations.com |
|
|
Source of Monetary or Material Support
|
| Heavenly Fuels Pvt Ltd
Basant Nagar, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Harikrishnan MD Ayu |
| Address |
Senior Research Fellow
Heavenly Fuel Pvt Ltd.
Basant Nagar, Chennai
|
| 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 Ram Madhavan MD |
Cancer Institute (WIA) |
S.K KRISHNAMURTHY CAMPUS
GANDHI MANDAPAM ROAD
ADYAR
Chennai
TAMIL NADU |
8281796896
drrammadhavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Cancer Institute (WIA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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 | Other than Classical | | (1) Medicine Name: STOMIST, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ECOG Performance status I and II
2. Patients treated with two opposing lateral fields
including parotid using 2D technique
3. Patients undergoing radiation or chemoradiation
|
|
| ExclusionCriteria |
| Details |
1. Lymphoma histology
2. Patients undergoing re irradiation
3. Patients with comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the change in the Clinical Oral Dryness Score from the baseline at the time of final assessment |
base line, completion of treatment, 3 months follow up and 6 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess whether the subjective scoring [Xerostomia Inventory score] is
correlating with the objective Clinical Oral Dryness Score
|
base line, completion of treatment, 3 months follow up and 6 months follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [drrammadhavan@gmail.com].
- For how long will this data be available start date provided 11-12-2023 and end date provided 11-12-2026?
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
|
• This is a pilot clinical study • Head and neck cancer patients undergoing radiation or chemoradiation will be
included in this study • All patients will be started on Oral Disintegration Tablet from Day 1 of chemoradiation and will be
continued for a period of 3 months • Assessment criteria - Xerostomia Inventory [subjective] and Clinical Oral
Dryness Score - CODS [objective] • Assessment - Base line [Prior to treatment], at completion of RT [1.5
months] , at first follow up [3 months] and at 6 months • The primary end point is to assess the change in CODS at 6 months from the
base line • The secondary end point is to assess whether the subjective scoring [Xerostomia Inventory score] is
correlating with the objective CODS |