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CTRI Number  CTRI/2024/05/067130 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 09/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Management of Radiation-Induced Oral Mucositis: Ayurveda Vs. Standard of Care in Oral Cancer: A Randomized Trial 
Scientific Title of Study   Comparative Effectiveness of Ayurveda (Ay) Intervention and Conventional Prophylaxis for Radiotherapy-Induced Oral Mucositis in patients undergoing Primary or Adjuvant Radiotherapy without Chemotherapy for Oral Cancers: A Prospective, Randomized, Open Label, Active-Controlled Pilot Study  
Trial Acronym  COMPAIR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zankhana Buch 
Designation  Chief Consultant 
Affiliation  Sri Shankara AyurVAID Centre for Integrative Oncology 
Address  Ground Floor, AyurVAID division, Sharada Kripa SSCHRC Campus Shankarpuram Basavanagudi

Bangalore
KARNATAKA
560004
India 
Phone  9739211166  
Fax    
Email  zankhana_buch@ayurvaid.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suprabha  
Designation  Lead- Clinical Research 
Affiliation  AyurVAID Hospitals 
Address  2nd floor Axis thillai 547 95th cross Above Indus Ind bank bank J P nagar 3rd Phase

Bangalore
KARNATAKA
560078
India 
Phone  8722810753  
Fax    
Email  suprabha_hegde@ayurvaid.com  
 
Details of Contact Person
Public Query  
Name  Dr Suprabha  
Designation  Lead- Clinical Research 
Affiliation  AyurVAID Hospitals 
Address  2nd floor Axis thillai 547 95th cross Above Indus Ind bank bank J P nagar 3rd Phase

Bangalore
KARNATAKA
560078
India 
Phone  8722810753  
Fax    
Email  suprabha_hegde@ayurvaid.com  
 
Source of Monetary or Material Support  
AyurVAID Hospitals, 2nd Floor, Axis Thillai, 547, 9th Cross Rd, above Indusind Bank, 3rd Phase, J. P. Nagar, Bengaluru, Karnataka 560078 
 
Primary Sponsor  
Name  AyurVAID Hospitals 
Address  2nd Floor Landmark Axis Thillai 547 9th Cross Road Above Indusind Bank 3rd Phase J.P. Nagar 
Type of Sponsor  Private hospital/clinic 
 
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 Suprabha Hegde  Sri Shankara Cancer Hospital and Research Centre, Bangalore  Ground floor, AyurVAID division, Sharada kripa,1st Cross, Shankaramutt Premises, Shankarapuram, Basavanagudi, Bangalore -560004
Bangalore
KARNATAKA 		 8722810753

suprabha_hegde@ayurvaid.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Shankara Cancer Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K123||Oral mucositis (ulcerative). Ayurveda Condition: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Benzadymine Mouthwash15ml of mouthwash for gargling, TID, for 7 weeks
2Intervention ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Astanga Hridaya, Procedure details: 15ml of kashaya to be held in the mouth for 3-5 min or till the patient can hold & spit it out.)
(1) Medicine Name: Saptachadadi Kashaya, Reference: Astanga Hridaya, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: tds, Duration: 7 Weeks
3Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Sushruta Samhita, Procedure details: 3 gm of powder with honey is applied inside the oral cavity & left for 15-20 min. can be rinsed with water if required)
(1) Medicine Name: Panchatikta ghrita with Honey, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Ghrita, Dose: 3(g), Frequency: tds, Duration: 7 Weeks
(2) Medicine Name: Yastimadhu Choorna, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Duration: 7 Weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.All oral cancer patients undergoing radiotherapy irrespective of type that are planned to be treated with primary or adjuvant Radiation Therapy using IMRT/3DCRT without chemotherapy.
2. Treatment plan is to receive a continuous course of IMRT/3DCRT delivered as single daily fractions with a cumulative radiation dose of 60-70 Gy. Planned radiation treatment fields must include at least two oral sites (left and right buccal mucosa, floor of mouth, left and right ventral/lateral tongue, soft palate) that are each planned to receive a total of ≥ 60 Gy.
3. Age 18 years or older
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
5. Serum pregnancy test negative for females of childbearing potential
6. Properly obtained written informed consent
 
 
ExclusionCriteria 
Details  1. Other Head and Neck Cancers, tumour of the larynx, hypopharynx, nasopharynx, sinuses, or salivary glands or past cancers with high risk of recurrence
2. Prior radiotherapy to the region of the Research cancer or adjacent anatomical sites or more than 25% of total body marrow-bearing area (potentially interfering with chemo tolerance)
3. Concurrent participation in another interventional clinical Research or use of another investigational agent within 30 days of the first dose of /Conventional care
4. Inability to eat soft solid food at baseline for reasons other than mouth soreness after surgery or dental procedures
5. Complete reliance on parenteral or gastrointestinal tube-delivered nutrition at baseline
6. Active infectious disease or ulcerative lesions or infections in the oral cavity at baseline
7. Presence of oral mucositis at baseline. (Subjects with mouth or throat pain solely due to post-operative effects are eligible.)
8. Known history of human immunodeficiency virus (HIV) or history of active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
9. Female patients who are pregnant or breastfeeding 10. Known allergies or intolerance to Ay/Conventional Care compounds

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Weekly reduction of the percent incidence and severity of OM, defined as the
proportion of subjects with any occurrence of WHO Grade 3 OM during the OM
Assessment period

2.Compare the Safety of Ay (SK+PGH and Conventional Care administered topically as
measured by:
 Frequency, duration, and severity of adverse events (AEs) and serious AEs
(SAEs) during the AE Observation Period;
 		 weekly assessment for 9 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the effectiveness of classical Ayurveda and Conventional Care prophylaxis during
the weekly RI-OM Assessment period on the following parameters:
2.Reduction in incidence and total number of days of Grade 3 OM
3.Patient outcome change in the pain scores on the Vanderbilt Head and Neck
Symptom Survey (VHNSS version 2)
4.Patient outcome change in Oral Pain scores (FACES Scale)
5.European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire Head & Neck module (EORTC-H&N) scores 		 Weekly assessment for 9 weeks  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3/ Phase 4 
Date of First Enrollment (India)   20/05/2024 
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="0"
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   This prospective, randomized, open-label, active-controlled Comparative Pilot study aimed to compare the effectiveness of Ayurveda intervention and conventional care in preventing or delaying grade 3 or higher oral mucositis (WHO Grading) in patients undergoing radiotherapy. The sample size in this study is 40. The consenting subjects will be randomized into two groups in 1 : 1 ratio. The Ayurveda intervention arm will be administered classical Ayurveda medicine for gargling and application in the oral cavity. The conventional care group will be given  Benzadymine mouthwash. The study period will be nine weeks, and follow-up will be performed every week. The trial is expected to be completed within 6 months. 
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