| CTRI Number |
CTRI/2025/05/086856 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
AYURVEDIC INTERVENTIONS IN RADIOTHERAPY INDUCED ORAL MUCOSITIS IN ORAL CANCER PATIENTS |
|
Scientific Title of Study
|
RANDOMIZED CLINICAL CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AYURVEDA INTERVENTIONS (TRIPHALA RASAYANA, HARIDRADI TAILA GANDUSHA) IN CHEMO /RADIOTHERAPY INDUCED ORAL MUCOSITIS IN ORAL CARCINOMA |
| Trial Acronym |
CHEMO- Chemotherapy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Gupta |
| Designation |
Sr. Prof & Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room No. 10
Department of Oral Medicine and Radiology
Maulana Azad Institute of Dental Sciences
MAMC Campus
BS Zafar Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
9810192165 |
| Fax |
|
| Email |
profsunitamamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Gupta |
| Designation |
Sr. Prof & Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 10
Department of Oral Medicine and Radiology
Maulana Azad Institute of Dental Sciences
MAMC Campus
BS Zafar Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
9810192165 |
| Fax |
|
| Email |
profsunitamamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Gupta |
| Designation |
Sr. Prof & Head of the Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 10
Department of Oral Medicine and Radiology
Maulana Azad Institute of Dental Sciences
MAMC Campus
BS Zafar Marg
New Delhi
Central
DELHI
110002
India |
| Phone |
9810192165 |
| Fax |
|
| Email |
profsunitamamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Medicines Pharmaceutical Corporation Ltd |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
AYUSH Bhawan B-Block
G.P.O Complex INA New Delhi-110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 Sunita Gupta |
Maulana Azad Institute of Dental Sciences |
Room No. 1
Department of Oral Medicine and Radiology
Maulana Azad Institute of Dental Sciences
Bahadur Shah Zafar Marg
New Delhi 110002
Central
DELHI |
9654700955
profsunitamamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:C01||Malignant neoplasm of base of tongue. Ayurveda Condition: MUKHAROGAH, (2) ICD-10 Condition:C050||Malignant neoplasm of hard palate. Ayurveda Condition: MUKHAROGAH, (3) ICD-10 Condition:C108||Malignant neoplasm of overlappingsites of oropharynx. Ayurveda Condition: MUKHAROGAH, (4) ICD-10 Condition:C090||Malignant neoplasm of tonsillar fossa. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhavaprakasha Madhyamakhanda Mukharogadhikar , Reference: 66/165, Route: Topical, Dosage Form: Taila, Dose: 450(ml), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 12 Weeks, Reference: No, Route: -, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Triphala Rasayana, Reference: Ch.Chi.1/1 62-74, Route: Oral, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (4) Medicine Name: 12 Weeks, Reference: Yes, Route: -, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Conventional | 1. Topical Application of 20% Benzocaine Gel B.D
for 12 weeks
2. 0.15% Benzydamine Mouthwash Swish and Spit 5 ml
B.D foe 12 weeks
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Oral, Oropharynx & Laryngeal Cancer patients diagnosed as Squamous Cell Carcinoma (Stage I to Stage IV).
2. Participants who are on conventional therapy (post-surgery radiotherapy and or chemotherapy with radiation, and chemotherapy).
3.Patients having Karnofsky Performance Status between 90-60.
4.Patients who will voluntarily give consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
Evidence of significant renal, hepatic, hematologic, or immunologic disease.
Inability to eat soft solid food at baseline
Patients who are judged by the investigators to be unsuitable to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical evaluation for changes in grading of oral Mucositis according to WHO Scale
Change in Quality of life in terms of EORTC QLQ C30. |
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in sleep quality in terms of Pittsburgh Sleep Quality Index (PSQI) |
Baseline, 12 week, 20 week & 60 week |
| Change in anxiety and depressive symptoms in terms of Hospital Anxiety and Depression Scale (HADS) |
Baseline, 12 week, 20 week & 60 week |
| Change in Pain in terms of Brief Pain Inventory (BPI) |
Baseline, 12 week, 20 week & 60 week |
| Change in ECOG Performance Status and Karnofsky Performance Status |
Baseline, 12 week, 20 week & 60 week |
| Change in Hematological & Inflammatory markers |
Baseline, 4 weeks, 12 weeks, 20 weeks & 60 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
23/05/2025 |
| 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 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
|
1. A total of 80 Patients will be recruited in the project titled ’’A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF TRIPHALA RASAYANA AND HARIDRADI TAILA GANDUSHA IN CHEMO /RADIOTHERAPY INDUCED ORAL MUCOSITIS IN ORAL CARCINOMA’’ after taking into consideration the inclusion & exclusion criteria.
2. The participants will be randomly allocated into two groups: Group A: 40 patients Group B: 40 patients
3. Detailed Clinical evaluation, blood investigations and the necessary questionnaire will be filled.
4. After the mucositis develops patients will be treated according to the allotted group: Group A : Participants receiving Ayurvedic Treatment Group B: Participants receiving Conventional Treatment
5. Patients will be followed up at regular intervals: 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks and 72 weeks. |