| CTRI Number |
CTRI/2026/04/109195 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Clinical effectiveness of nanogel of Acorus calamus and Butea monosperma with Carbamazepine in the treatment of trigeminal neuralgia-A clinical trial |
|
Scientific Title of Study
|
Comparison,Formulation,Characterisation and Clinical effectiveness of nanogel of Acorus calamus and Butea monosperma with Carbamazepine in the treatment of trigeminal neuralgia-A 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 |
Selva sigamani V |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha dental college |
| Address |
Saveetha dental college
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
06382125228 |
| Fax |
|
| Email |
152310003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Selva sigamani V |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha dental college |
| Address |
Saveetha dental college,
Velappanchavady post,
Chennai-600077.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
06382125228 |
| Fax |
|
| Email |
152310003.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Selva sigamani V |
| Designation |
Postgraduate student |
| Affiliation |
Saveetha dental college |
| Address |
Saveetha dental college
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
06382125228 |
| Fax |
|
| Email |
152310003.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha dental college |
| Address |
saveetha dental college, velappanchavady post, Poonamalle, chennai-600077 |
| Type of Sponsor |
Other [Private dental 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 |
| Selva sigamani V |
Saveetha dental college |
Saveetha dental college
Thiruvallur
TAMIL NADU |
06382125228
152310003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acorus calamus with carbamazepine, Butea monosoperma with carbamazepine |
Acorus calamus and Butea monosperma are herbal plants that have neuroprotective properties similar to carbamazepine |
| Comparator Agent |
carbamazepine |
Acorus calamus and Butea monosperma are herbal plants, both have the property of neuroprotective properties similar to carbamazepine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Trigeminal neuralgia
|
|
| ExclusionCriteria |
| Details |
TMDs
Other neuralgias |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the pain intensity |
Reduction in the pain intensity |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improving the QOL
Assess Pre and post treatment phases |
|
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/05/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
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 - NO
|
|
Brief Summary
|
The International Association of Pain defines trigeminal neuralgia as a sudden, unilateral, severe, brief, stabbing, and recurrent pain along the course of the distribution of the trigeminal nerves. Carbamazepine is an anticonvulsant as well as an antiepileptic drug, which is considered a gold standard drug in the treatment of trigeminal neuralgia.ommon side effect of bone marrow suppression, causing agranulocytosis and drowsiness. Agranulocytosis is more dangerous when the total neutrophil count decreases to 100 cells/mm3. Root rhizomes of Acorus calamus has a property such as anticancer properties, antioxidant properties, and neuroprotective properties by inhibiting the action of calcium channels, which the mainly responsible for the pain conduction pathway. By inhibiting the calcium channel inhibitory action, it greatly reduces the pain intensity as well. the flowers of Butea monosperma have neuroprotective properties as well as antioxidant and calcium channel inhibitory action. |