| CTRI Number |
CTRI/2025/10/095903 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to evaluate the outcomes of Integrative multimodal Ayurveda treatment in the management of oral cancers |
|
Scientific Title of Study
|
An observational study to evaluate the outcomes of Integrative multimodal Ayurveda treatment in the management of oral cancers: Prospective Cohort study |
| 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 Kajal Singh |
| Designation |
MD Scholar, Department of Kayachikitsa |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, Academic block, Block C, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
6350523150 |
| Fax |
|
| Email |
kajal130198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R K Yadava |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, Academic block, Block C, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9412148437 |
| Fax |
|
| Email |
drrky68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R K Yadava |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Kayachikitsa, 6th floor, Academic block, Block C, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi
DELHI
110076
India |
| Phone |
9412148437 |
| Fax |
|
| Email |
drrky68@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New 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 Kajal Singh |
All India Institute of Ayurveda |
Cancer OPD ICCU, Room No. 109-C, 1st Floor, Hospital Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura road, New Delhi 110076
New Delhi
DELHI |
6350523150
kajal130198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Ayurveda, New Delhi |
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: ARBUD, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nil | (Procedure Reference: nil, Procedure details: nil)
|
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Histopathologically confirmed cases of oral cancer of any type and stage with or without ongoing conventional care.
2 Willingness to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1 Patient with other types of pathologies involving oropharyngeal organs.
2 Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Change in QoL based EORTC scores
2 Change in symptom severity |
1 Clinical observations recorded at every 15/30 days for 90 days
2 QoL assessments
EORTC QLQ-H&N35, EORTC QLQ-C30, Karnofsky performance scale, FACT-GP (Version 4)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Compliance rate
2 ADRs, Adverse events
3 Come up with the draft suggesting the trend to present clinical practice in cancer & further may help for developing a protocol |
1 Observations recorded at every 15/30 days for 90 days
2 QoL parameters will be assessed |
|
|
Target Sample Size
|
Total Sample Size="276"
Sample Size from India="276"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="1"
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 - None of the above
- 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 (Others) - Through proper channel of concerned organisation
- For how long will this data be available start date provided 31-12-2027 and end date provided 31-12-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Aim- To evaluate the outcomes of Integrative multimodal Ayurveda treatment in oral cancer management, with focus on clinical outcomes like changes in symptoms, laboratory parameters (haematological and biochemical), radiological investigations and inflammatory markers, and quality of life- in patients diagnosed with oral cancer.
Primary Objective- To observe, document and assess the clinical outcomes (quality of life, symptom relief) in oral cancer patients undergoing Integrative multimodal Ayurveda treatment. 1. To evaluate the safety, tolerability, and patient compliance with Ayurvedic interventions. 2. To observe and document ADR and/or AEs, if any. 3. To identify the possible conditions in Ayurveda akin to oral cancer. |