| CTRI Number |
CTRI/2026/02/103085 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of intake of oral carbamazepine and oral boswellia curcumin in pain reduction in Trigeminal Neuralgia patients |
|
Scientific Title of Study
|
Evaluation of the efficacy of oral Carbamazepine therapy versus oral Carbamazepine Boswellia Curcumin combination therapy and oral Boswellia curcumin monotherapy in patients with Trigeminal Neuralgia A Randomized Controlled Trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khajal K |
| Designation |
Principal Investigator |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Tamilnadu Government Dental College and Hospital, TNPSC road, Chennai - 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9487810853 |
| Fax |
|
| Email |
kkhajal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L.Kayal |
| Designation |
Guide and Professor |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Professor, Department of Oral Medicine and Radiology, Tamilnadu Government Dental College and Hospital, TNPSC road, Chennai - 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9445170282 |
| Fax |
|
| Email |
dr.lkayal.kumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khajal K |
| Designation |
Principal Investigator |
| Affiliation |
Tamilnadu Government Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology, Tamilnadu Government Dental College and Hospital, TNPSC road, Chennai - 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9487810853 |
| Fax |
|
| Email |
kkhajal1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Khajal K |
| Address |
Department of Oral Medicine and Radiology TNPSC road TNGDCH |
| Type of Sponsor |
Other [SELF] |
|
|
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 Khajal K |
Tamilnadu Government Dental College and Hospital |
Department of Oral Medicine and Radiology, Tamilnadu Government Dental College and Hospital, TNPSC road, Chennai - 600003
Chennai
TAMIL NADU |
09487810853
kkhajal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G440||Cluster headaches and other trigeminal autonomic cephalgias (TAC). Ayurveda Condition: ANANTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Boswellia Curcumin, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Carbamazepine | 200 mg BID for 4 months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were diagnosed with Trigeminal Neuralgia for the first time
Patient willing to participate in the study and has the ability to complete the study |
|
| ExclusionCriteria |
| Details |
Patients who were previously diagnosed with Trigeminal Neuralgia
Not willing to participate in the study
Lactating or pregnant women
Allergic, immunocompromised or systemic illness patients
Asymptomatic patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tablet Boswellia Curcumin if found to be effective in patients with Trigeminal Neuralgia can be used as a single modality of treatment or as an adjunctive therapy in future in cases of Trigeminal Neuralgia |
Tablet Boswellia Curcumin if found to be effective in patients with Trigeminal Neuralgia can be used as a single modality of treatment or as an adjunctive therapy in future in cases of Trigeminal Neuralgia Week 0,2,6,15 and 4 Months |
|
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Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - 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 - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [kkhajal1998@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized controlled clinical trial conducted at the Department of Oral Medicine and Radiology, Tamil Nadu Government Dental College and Hospital, Chennai, to evaluate and compare the efficacy of three treatment modalities in patients with newly diagnosed trigeminal neuralgia. A total of 63 patients will be randomly allocated into three groups: Group A receiving oral carbamazepine (200 mg twice daily), Group B receiving a combination of oral carbamazepine (200 mg) and Boswellia–Curcumin (500 mg) twice daily, and Group C receiving oral Boswellia–Curcumin monotherapy (500 mg twice daily), all for a duration of 15 week. Diagnosis will be made based on International Headache Society criteria, supported by clinical examination and local anesthetic nerve block testing. Patients will be followed up at 2, 6, and 15 weeks. Treatment efficacy will be assessed using the Modified Brief Pain Inventory (BPI), evaluating pain intensity and frequency of paroxysms. Statistical analysis will be performed using SPSS version 26. The study aims to determine whether Boswellia–Curcumin, alone or in combination with carbamazepine, offers comparable or improved pain control with potentially fewer adverse effects compared to conventional carbamazepine therapy |