| CTRI Number |
CTRI/2025/03/082204 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Willow bark extract for acute pulpal pain patients |
|
Scientific Title of Study
|
to assesss and compare the efficacy of willow bark extract with ibuprofen for patients with acute pulpal pain -a randomized placebo controlled double blinded clinical trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BVINU PRIYA |
| Designation |
M.D.S |
| Affiliation |
SRM |
| Address |
SRM Dental college ,Bharathi salai ,Ramapuram,Chennai-89
SRM Dental college ,Oral medicine and radiology department
Chennai
TAMIL NADU
600089
India |
| Phone |
9677322827 |
| Fax |
|
| Email |
vinupriyab8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BVINU PRIYA |
| Designation |
M.D.S |
| Affiliation |
SRM |
| Address |
SRM Dental college ,Bharathi salai ,Ramapuram,Chennai-89
SRM Dental college ,Bharathi salai ,Ramapuram,Chennai-89
Chennai
TAMIL NADU
600089
India |
| Phone |
9677322827 |
| Fax |
|
| Email |
vinupriyab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BVINU PRIYA |
| Designation |
M.D.S |
| Affiliation |
SRM |
| Address |
SRM Dental college ,Bharathi salai ,Ramapuram,Chennai-89
SRM Dental college ,Oral medicine and radiology department
Chennai
TAMIL NADU
600089
India |
| Phone |
9677322827 |
| Fax |
|
| Email |
vinupriyab8@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.Vinu priya,SRM dental college,no.2 bharathi salai,ramapuram,chennai-600089. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
- |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| BVINU PRIYA |
SRM Dental College |
Department of oral medicine and radiology,SRM Dental College,bharathi salai,
ramapuram,
chennai,Tamil Nadu
Department of oral medicine and radiology,SRM Dental College,bharathi salai,
ramapuram,
chennai,Tamil Nadu
Chennai
TAMIL NADU |
9677322827
vinupriyab8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM-Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition:K040||Pulpitis. Ayurveda Condition: shool, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patient who are willing to participate in the
study.
(2) Patients of age between 16 and 45 years.
(3) Patients with Dental caries with Acute pulpal pain.
|
|
| ExclusionCriteria |
| Details |
(1)History of any allergic reaction to herbal
preparations.
(2) Pregnancy & Lactating women
(3)Patients with gastric irritation and any other systemic illness and undergoing treatment for the same.
(4) Patients with other orofacial pain and swelling.
(5) Patients with involvement of acute pulpal pain in multiple teeth.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess efficacy of Willow bark extract and compare with ibubrufen |
pain score noted after 6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the efficacy of willow bark to that of ibuprofen |
at the end of 2nd month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
04/04/2025 |
| 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="0"
Months="2"
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
|
Odontogenic pain refers to pain initiating from the teeth or their supporting structures, the mucosa, gingivae, maxilla, mandible or periodontal membrane. The overall pooled prevalence of toothache in children and adolescents was 36.2% and patients with dental caries have 3.49 times more chance of reporting toothache according to literature. Evidence gathered from studies and the work of others appears to support the presence of two distinct nerve pain pathways in the dental pulp, represented by fast conducting A-delta and slow conducting C-fibers. Each of these types of fibers has different pain characteristics: A-delta fibers evoke a rapid, sharp, lancinating pain reaction, and C-fibers cause a slow, dull, crawling pain. Usually for management of odontogenic pain, Non Steroidal Anti-inflammatory drugs (NSAIDS) are prescribed which decrease the production of prostaglandins thereby decreasing the intensity of pain. Most commonly prescribed are ibuprofen (400 mg ) , naproxen (500 mg),Aspirin (600 mg) .Although NSAIDs are safe if used for a short period of time, they may cause heartburn, nausea, vomiting, diarrhea, and in some cases potentially serious adverse effects such as gastric ulcer gastric perforation , and cardiovascular risks. Hence ,there is a need for alternative medicinal therapy. One such safer method is Phytotherapy (Herbal medicine).So, these emerging trends can meet the changing demands of the patients. Herbal medicines are safe , since they are found in nature, such remedies are assumed to be safer than NSAIDs. Furthermore, the value of many of the herbs has been celebrated throughout ages, without any mention of detrimental side effects. One of the modern advances in herbal therapy is the use of willow bark (Salix Alba). The chemical oxidation of salicin, a known constituent of the bark of the willow tree (Latin name: Salix), resulted in a new substance termed ‘salicylic acid’, and the acetylated derivative of this substance eventually turned into one of the most successful drugs in history, Aspirin. According to the literature 240 mg salicin/day will produce no more than115mg of salicylic acid and would therefore not be expected to produce analgesic or anti-inflammatory action of salicylic acid. However, Willow bark extract has been used in required amount because of its anti-inflammatory, antianalgesic, and antipyretic action in few earlier studies . |