| CTRI Number |
CTRI/2026/02/104799 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Capsicum annuum Glycerol for the Management of Oral Mucositis(Mouth Sores) |
|
Scientific Title of Study
|
An Experimental Randomised Clinical Trial on Effectiveness of Capsicum annuum Glycerol in the management of Oral Mucositis assessed by Oral Mucositis Assessment Score |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupaben Harishbhai Sailor |
| Designation |
MD Scholar |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine And Hospital |
| Address |
Department Of Homoeopathic Pharmacy Divison Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
8780999878 |
| Fax |
|
| Email |
sailorkrupa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Santosh Mahale |
| Designation |
Professor of Homoeopathic Pharmacy Department |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine And Hospital |
| Address |
Department Of Homoeopathic Pharmacy Divison Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
9825290925 |
| Fax |
|
| Email |
rajeshmahale4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krupaben Harishbhai Sailor |
| Designation |
MD Scholar |
| Affiliation |
C D Pachchigar College of Homoeopathic Medicine And Hospital |
| Address |
Department Of Homoeopathic Pharmacy Divison Of MD 2nd Floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat
Surat
GUJARAT
395001
India |
| Phone |
8780999878 |
| Fax |
|
| Email |
sailorkrupa@gmail.com |
|
|
Source of Monetary or Material Support
|
| C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat 395001 Gujarat India |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
| Address |
C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat 395001 Gujarat India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Krupaben Harishbhai Sailor |
C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 395001 |
Department of Homoeopathic Pharmacy Division of MD 2nd floor C D Pachchigar College Of Homoeopathic Medicine And Hospital Near Navjivan Circle Udhna Magdalla Road Surat 395001
Surat
GUJARAT |
8780999878
sailorkrupa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of C D Pachchigar College of Homoeopathic Medicine And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K123||Oral mucositis (ulcerative), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Capsicum annuum Glycerol (Homoeopathic Preparation) |
Patients Diagnosed with oral mucositis will recieve Capsicum annuum mother tincture in Glycerol base for local application over the affected oral mucosa.The medication will be applied topically.The frequency of application may be adjusted on severity of oral mucositis,as per protocol guidline.Total duration of intervention 9 months of topical Capsicum Annuum glycerol application, duration adjusted according to severity of case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 65 years,of either gender, clinically diagnosed with oral mucositis and having measurable baseline Oral mucositis assessment score, willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with serious systemic illness such as HIV/AIDS.
Patients with known allergy to Capsicum annuum or glycerol.
Patients unwilling to give written informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oral Mucositis Assessment Score measured at baseline and at the end of treatment.The
effectivenss of intervention will be evaluated by comparing pre and post treatment scores. |
9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to clinical improvement in oral mucositis as per oral mucositis assessment score,percentage reduction in oral mucositis assessment score from baseline to post treatment,Patient satisfaction & improvement in quality of life with the intervention. |
9 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
AIM :
To evaluate the efficacy of capsicum annuum glycerol in the management of oral mucositis through an experimental clinical trial.
OBJECTIVE :
1)To assess the clinical effectiveness of Capsicum annum glycerol preparation for reducing erythema and ulcer size patients with oral mucositis using Oral Mucositis Assessment Scale.
2)To assess patient’s reported satisfaction and improvement in quality of life after treatment.
HYPOTHESIS :
1. NULL HYPOTHESIS (H0):There is no significant reduction in Oral Mucositis Assessment score in oral mucositis treated with Capsicum annuum glycerol.
2. ALTERNATIVE HYPOTHESIS(H1) :There is a significant reduction in Oral Mucositis Assessment Score in oral mucositis treated with Capsicum annuum glycerol.
METHODS OF DATA COLLECTION AND OUTCOME MEASUREMENT :
Patients attending the Out-Patient Department of C.D.Pachchigar College of Homoeopathic Medicine And Hospital , peripheral outpatient units diagnosed with oral mucositis will be screened according to predefined inclusion and exclusion criteria. Eligible patients will be enrolled after obtaining written informed consent.
Detailed case history including demographic data, medical history, duration, grade and clinical features of oral mucositis will be recorded in a specially designed Case Record Form (CRF).
Baseline assessment of oral mucositis severity will be done using the Oral Mucositis Assessment Score (OMAS) prior to initiation of treatment.
All enrolled participants will receive topical application of Capsicum annuum glycerol over the affected oral mucosa as per study protocol for the specified duration.
Follow-up assessments will be conducted at predetermined intervals (e.g., Day 7, Day 14 and Day 21 / Day 28 as per protocol). At each follow-up visit, severity of oral mucositis will be reassessed using Oral Mucositis Assessment Score.
Outcome Measurement :
Reduction in Oral Mucositis Assessment Score (OMAS) from baseline to end of treatment.
Effectiveness of the intervention will be evaluated by comparing pre-treatment (baseline) and post-treatment Oral Mucositis Assessment Scores.
Adverse events, patient compliance and any additional treatment required will be recorded at each follow-up visit.
Data obtained will be subjected to appropriate statistical analysis to determine the effectiveness of Capsicum annuum glycerol in the management of oral mucositis.This research study will be started only after approved by ethical committee,registration in Veer Narmad South Gujarat University and registration under Clinical Trial Registry of India.
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