CTRI/2025/03/083336 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On:
10/03/2025
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
A Study to Compare Add on Ayurvedic Treatment Versus Only Conventional Care in Modern Medicine to Improve Quality of Life for Advanced Head and Neck Cancer Patients
Scientific Title of Study
Efficacy of Comprehensive Ayurvedic Treatment (CAT) as Add-On to Conventional Bio-Medicine in Improving the Quality of Life (Qol) in Unresectable Stage III-IVB Head-Neck Squamous Cell Carcinoma (HNSCC) Patients: An Assessor Blind Randomized Controlled Trial, CATCH Trial
Trial Acronym
CATCH
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Gayatri Muthiyan
Designation
Additional Professor
Affiliation
All India Institute Of Medical Sciences Nagpur
Address
Room No. 107, First floor Department of Anatomy, College Buidling, AIIMS Nagpur,Plot no. 2, MIHAN, Nagpur All India Institute Of Medical Sciences Nagpur
Plot no.2, Sector-20, MIHAN, Nagpur 441108 Nagpur MAHARASHTRA 441108 India
Phone
9322870196
Fax
Email
gayatrimuthiyan@aiimsnagpur.edu.in
Details of Contact Person Scientific Query
Name
Dr Gayatri Muthiyan
Designation
Additional Professor
Affiliation
All India Institute Of Medical Sciences Nagpur
Address
Room No. 107, First floor Department of Anatomy, College Buidling, AIIMS Nagpur,Plot no. 2, MIHAN, Nagpur All India Institute Of Medical Sciences Nagpur
Plot no.2, Sector-20, MIHAN, Nagpur 441108 Nagpur MAHARASHTRA 441108 India
Phone
9322870196
Fax
Email
gayatrimuthiyan@aiimsnagpur.edu.in
Details of Contact Person Public Query
Name
Dr Amit Nakanekar
Designation
Assistant Professor, Kayachikitsa
Affiliation
Government Ayurvedic College and Hospital Nagpur
Address
Department of Kayachikitsa
Government Ayurvedic College
Raje Raghuji Nagar,
Sakkardara , Nagpur Chota Tajbag Road, Ayurvedic Layout, Sakkardara Chowk, Nagpur, Maharashtra 440024 Nagpur MAHARASHTRA 440024 India
Phone
9850233016
Fax
Email
amitnakanekar@gmail.com
Source of Monetary or Material Support
All India Instituite of Medical Sciences Nagpur, Plot No 2, Sector 20, MIHAN, Nagpur, Maharashtra - 440008 (India)
Indian Council of Medical Research (Ministry of Health & Family Welfare, Govt. of India), Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi 110029 (India)
Ministry of AYUSH, Central Council for Research in Ayurvedic Sciences,
Jawaharlal Nehru Bharatiya Chikitsa Evam Homoeopathy Anusandhan Bhawan,
No 61-65,Institutional Area, Opp D block, Janakpuri, New Delhi 110058 (India)
Primary Sponsor
Name
Indian Council of Medical Research and Central Council for Research in Ayurvedic Sciences
Address
Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi-29 and JNBCEH Anusandhan Bhawan, No 61-65, Opp D block, Janakpuri, New Delhi-58 (India)
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Gayatri Muthiyan
All India Institute of Medical Sciences Nagpur
Ayush-ICMR Advanced Centre for Integrative Health Research (AI-ACIHR), Room No. 34-37, First floor, AYUSH building, AIIMS Nagpur, Plot No.2, Sector 20, MIHAN, Nagpur -440008 (India) Nagpur MAHARASHTRA
9322870196
gayatrimuthiyan@aiimsnagpur.edu.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
AIIMS Nagpur
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx. Ayurveda Condition: ARBUDAH, (2) ICD-10 Condition:C01||Malignant neoplasm of base of tongue. Ayurveda Condition: ARBUDAH, (3) ICD-10 Condition:C13||Malignant neoplasm of hypopharynx. Ayurveda Condition: ARBUDAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Comparator Arm (Non Ayurveda)
-
Standard of Care Coventional Treatment Module
1. Patients will be given conventional radiotherapy total dose of 70 Gy in 35 fractions over 7 weeks (2 Gy/fraction, 5 days in a week) to gross primary and nodal disease along with concurrent cisplatin 40 mg/m2 per week.
2. The cisplatin-based therapy will be administered for 5-7 cycles
3. Prior to administration of cisplatin, the standard of care will be initiated that includes Inj. Dexamethasone 16 mg (2 amp), Inj Ranitidine 50 mg (1 amp) and Inj Ondansetron 8 mg (1 amp) in 500 ml 0.9% NS for 45 minutes.
4. This will be followed by administration of 500 ml 0.9% NS for 45 minutes. Then, Inj Mannitol (20%) 100 ml over 15-20 minutes will be administered.
5. Following this, cisplatin 40 mg/m2 per week will be administered in 500 ml 0.9% NS for 60 minutes.
6. Finally, Inj KCl 20 mmol and Inj MgSO4 10 mmol in 1000 ml of 0.9% NS is administered for 2 hours
2
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Ayush Qol 2C, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: All the Ayurvedic medicines and Procedures will be done as a add on to standard of care module
3
Intervention Arm
Procedure
-
mAtrAbastiH, मात्राबस्तिः
(Procedure Reference: Ashtanga Hridayam Sutrasthan, Procedure details: 3. Three cycles of Matra Basti (each cycle 8 days) Narayan taila[42] (80 ml-100ml) [API, Part II, Vol IV]) (1) Medicine Name: Narayana Taila, Reference: 42. Tripathi B ,Sharangdhara Samhita:,(Dipika hindi commantary);, Chaukhamba Surabharti Prakashan Varanasi,2016,Madhyamkhanda, Adhyaya 9,page no .153 shlock 101-110 , Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 24 Days
4
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Conventional Standard of Care, Reference: NA, Route: Topical, Dosage Form: Capsules, Dose: 40(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: Conventional Standard of Care as per Comparator arm will be given . Ayurvedic treatment will be add on to Standard of care treatment
5
Intervention Arm
Procedure
-
nasyam/ nastam, नस्यम्/ नस्तम्
(Procedure Reference: Ashtang Hridayam Sutrasthan, Procedure details: One cycle of Nasya (7 days) with Panchtikta Ghrit (4-10 drops in each nostril once a day)) (1) Medicine Name: Panchtikta Ghrit, Reference: API, Part II, Vol I, Route: Nasal, Dosage Form: Ghrita, Dose: 10(drops), Frequency: od, Duration: 7 Days
6
Intervention Arm
Procedure
-
kavalaH, कवलः
(Procedure Reference: Ashtang Hridayam Sutrasthan, Procedure details: Kawal (Gargles) with decoction of Triphala and Yashtimadhu Churna twice daily) (1) Medicine Name: Triphala and Yashtimadhu Kwath, Reference: Sharangdhara Samhita,Madhyamkhanda, Adhyaya 2 and Dravyaguna viyana vol II, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: bd, Duration: 6 Months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1) Unresectable histologically proven Head and Neck Squamous cell carcinoma patients,
2) Head and neck cancer with stage III to IVB
3) Age group of 18 to 70 years
4) Eastern Co operative Oncology Group ECOG performance status grade 0 to 1,
5) Haematological profile Haemoglobin level greater than 10 mg per dl, Total Leukocyte count greater than 4000 per mm3, platelet count greater than 100000 per mm3, adequate serum creatinine 0.6 to 1.5 mg per dl, ALT 0 to 45 U per L
6) Normal electrocardiogram
ExclusionCriteria
Details
1) Those who are not willing to give consent
2) Carcinoma of nasopharynx, nasal cavity and paranasal sinuses
3) Patients with prior history of cancer, or synchronous malignancy
4) Prior history of lactose intolerance, enrolment in other trial or use of ayurvedic medicines
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Mean change in total EORTC H&N35, EORTC H&N43, FACT-HN score in both treatment arms
From baseline to 6 months
Secondary Outcome
Outcome
TimePoints
1. Mean change in expression of cytokines and epigenetic markers in both arms
2. Mean change in BDI scores
3. Frequency of adverse drug reactions reported with integrated Ayurveda care
4. Percentage compliance for add-on CAT therapies
From baseline to 6 months
Target Sample Size
Total Sample Size="100" Sample Size from India="100" 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)
16/08/2025
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="6" 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
Rationale/Gaps in Existing Knowledge
Head and Neck Cancer (HNC) is a major public health concern in India, with late-stage presentation and poor survival rates. Conventional treatments (radiotherapy, surgery) are effective but cause debilitating side effects, negatively impacting patients’ Health-Related Quality of Life (HR-QoL). Patients seek complementary and alternative medicine (CAM) to manage these side effects, but its safety and efficacy with conventional treatment is unclear.
Novelty
The present study examines the integrative oncology approach by incorporatingComprehensive Ayurveda Treatment (CAT) as add-on with conventional HNC treatment in Central India. CAT, a holistic system, presents a novel and cost-effective array of therapies, including panchgavya, triphala, yoga etc. with potential applications in the management of HNCs.
Objectives
To compare the effectiveness of add-on CAT therapies with standard care versus only standard care in unresectable stage III – IVB head-neck squamous cell carcinoma (HNSCC) patients, w.r.t. health-related quality-of-life (HR-QoL) (primary), expression of biochemical and epigenetic markers, psychological distress,and its safety (secondary).
Methods
This study is an Assessor blind Open labelled Parallel group Randomized Controlled Trial, conducted at tertiary care centre. Total of 100 cases (50 in each arm) of unresectable histologically proven stage III - IVB HNCs will be recruited after a comprehensive screening process as per inclusion and exclusion criteria: involving haematological, radiographic etc. assessments for final inclusion and staging. They will be stratified: control arm receiving standard treatment with Concomitant Chemoradiotherapy (CRT) with modern volumetric arc modulated radiotherapy (VMAT) and trial arm receiving CAT therapies as add-on to standard treatment. Regular evaluations by clinicians and Ayurvedic experts will occur periodically, including physical examinations and relevant investigations (radiological, cytokines, epigenetic markers etc.) to monitor treatment progress and outcomes (QoL, Psychological distress, safety and efficacy).
Expected Outcomes
1) Improved patient QoL and symptom management in HNC
2) Evaluation of the feasibility, safety, and preliminary efficacy of this integrative paradigm in the clinical context.
Develop evidence-based guidelines for integrating CAT therapies into HNC care, to empower these patients and improve HNC management in India.