| CTRI Number |
CTRI/2025/02/080539 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy Of Arnica Montana for evaluation of pain, swelling
and difficulty in mouth opening followed by surgery of removal of mandibular third molar which is stuck in difficult position in bone |
|
Scientific Title of Study
|
Efficacy of Arnica Montana for evaluation of pain , swelling and trismus followed by extraction of impacted mandibular third molar surgery |
| 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. Revati Naidu |
| Designation |
Post graduate student |
| Affiliation |
School of Dental Sciences ,Krishna Vishwa Vidyapeeth |
| Address |
Room no.24 , department of oral and maxillofacial surgery , School of Dental Sciences, Krishna Vishwa Vidyapeeth
Satara
MAHARASHTRA
415539
India |
| Phone |
9881565018 |
| Fax |
|
| Email |
nrevati1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mouneshkumar CD |
| Designation |
Professor |
| Affiliation |
SCHOOL OF DENTAL SCIENCES ,KRISHNA VISHWA VIDYAPEETH |
| Address |
Room no. 24 , Department of Oral and Maxillofacial Surgery , School of Dental Sciences, Krishna Vishwa Vidyapeeth
Satara
MAHARASHTRA
415539
India |
| Phone |
7709307635 |
| Fax |
|
| Email |
drmouneshkumarchapi07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Revati Naidu |
| Designation |
Post graduate student |
| Affiliation |
School of Dental Sciences, Krishna Vishwa Vidyapeeth |
| Address |
Room no. 24 , Department of Oral and Maxillofacial Surgery , School of Dental Sciences, Krishna Vishwa Vidyapeeth
Satara
MAHARASHTRA
415539
India |
| Phone |
9881565018 |
| Fax |
|
| Email |
nrevati1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Vishwa Vidyapeeth , Malkapur, Karad ,India -415539 |
|
|
Primary Sponsor
|
| Name |
Krishna Vishwa Vidyapeeth |
| Address |
Krishna Vishwa Vidyapeeth , Malkapur, Karad ,India -415539 |
| 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 Revati Naidu |
School of Dental Sciences, Krishna Vishwa Vidyapeeth |
Room No. 24 ,Department of Oral and Maxillofacial Surgery
Satara
MAHARASHTRA |
9881565018
nrevati1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arnica Montana |
Group A : Control group – Will be recieving Antibiotics- Amoxicillin 500mg/3 times a day, Analgesic- Paracetamol 500mg/ 3 times a day , Antacid -Pantoprazole 40 mg / once a day before breakfast
Group B: Study group – Arnica Montana tablets (sublingually)
(1) 4 tablets 1 hour before the procedure (Day 0);
(2) 4 tablets×4 times/day starting 1 hour following extraction of mandibular 3rd molar ( Day 0 -total 16 tablets)
(3) 4 tablets×4 times/day on Day 1 (total of 16 tablets)
(4) 4 tablets×4 times/day on Day 2 (total of 16 tablets)
(5) 4 tablets×4 times/day on Day 3 (total of 16 tablets).
Along with Arnica Montana they will also be prescribed antibiotics- amoxicillin 500mg/3 times a day, analgesic- paracetamol 500mg/ 3 times a day , antacid -pantoprazole 40 mg / once a day before breakfast
|
| Comparator Agent |
Arnica Montana |
to compare pain ,swelling and trismus after surgical extraction of third molar after giving ARNICA Montana along with NSAID agent as well for study group and giving only NSAID for control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in between the age group 18 to 45 years.
2. Impacted mandibular 3rd molar with classes I and II surgical difficulty and depth level of A or B indicated for extraction based on Pell-Gregory classification
3. Patient willing for participation in study.
4. No recent history of using NSAIDs or corticosteroids in last 2 weeks.
5. No known underlying medical condition which may affect the outcome
|
|
| ExclusionCriteria |
| Details |
1. Patient with contraindication to Arnica Montana therapy such as pregnant and breastfeeding women.
2. No active smoking of any type
3. Known allergy to Arnica Montana
4. Medically compromised patients
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the decrease in pain, swelling and trismus |
day 1, day 3 day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| faster reduction of pain ,swelling and trismus after giving Arnica Montana along with NSAID |
day 1, day 3 day 7 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
02/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 - Proposals should be directed to [nrevati1@gmail.com].
- For how long will this data be available start date provided 13-02-2027 and end date provided 13-02-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aim of this study is to evaluate the clinical
efficacy of Arnica Montana (AM) in reduction following extraction of impacted
mandibular 3rd molars
To evaluate swelling, pain and trismus post
extraction after receiving Arnica montana tablets orally post surgical
extraction of impacted third molar Duration of study : 18 months Each patient will undergo surgical removal of mandibular
third molar under local anaesthesia.
Group A : Control group – Will be recieving Antibiotics- Amoxicillin 500mg/3 times a day, Analgesic- Paracetamol
500mg/ 3 times a day , Antacid -Pantoprazole 40 mg / once a day
before breakfast
Group B: Study group – Arnica Montana tablets (sublingually)
(1) 4
tablets 1 hour before the procedure (Day 0);
(2) 4
tablets×4 times/day starting 1 hour following extraction of mandibular 3rd
molar ( Day 0 -total 16 tablets)
(3) 4
tablets×4 times/day on Day 1 (total of 16 tablets)
(4) 4
tablets×4 times/day on Day 2 (total of 16 tablets)
(5) 4
tablets×4 times/day on Day 3 (total of 16 tablets)
Along with Arnica Montana they will also be prescribed
antibiotics-
amoxicillin 500mg/3 times a day, analgesic- paracetamol
500mg/ 3 times a day , antacid -pantoprazole 40 mg / once a day
before breakfast
|