| CTRI Number |
CTRI/2026/02/103029 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate the role of a herbal capsule in healing of lower jaw fractures
|
|
Scientific Title of Study
|
Evaluation of the osteogenic potential of Cissus Quadrangularis capsule in Mandibular fracture healing- A Single Blind Randomized Control 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 |
Dr Ajay A |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
no 420, 4 th floor, Sri Venkateshwaraa Dental College, Ariyur, Puducherry 605 102
no 420, 4 th floor, Sri Venkateshwaraa Dental College, Ariyur, Puducherry 605 102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9080630562 |
| Fax |
|
| Email |
ajayaj04893@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr yuvaraj |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
no 420, 4 th floor, Sri Venkateshwaraa Dental College, Ariyur, Puducherry 605 102
no 420, 4 th floor, Sri Venkateshwaraa Dental College, Ariyur, Puducherry 605 102
Pondicherry
PONDICHERRY
605106
India |
| Phone |
9080630562 |
| Fax |
|
| Email |
omfssvdc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay A |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Dental College |
| Address |
no 420, 4 th floor, Sri Venkateshwaraa Dental College, Ariyur, Puducherry 605 102
no 420, 4 th floor, Sri Venkateshwaraa Dental College, Ariyur, Puducherry 605 102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9080630562 |
| Fax |
|
| Email |
ajayaj04893@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ajay A |
| Address |
No 420, 4 th Floor, department oral and maxillofacial surgery, Sri venkateshwaraa dental college, ariyur, puducherry 605102 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Ajay A |
Sri Venkateshwaraa Dental College |
no 420, 4th floor, Department of oral and maxillofacial surgery, Sri venkateshwaraa Dental College ariyur, Puducherry 605 102
Pondicherry
PONDICHERRY |
09080630562
ajayaj04893@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:S026||Fracture of mandible. Ayurveda Condition: BAGNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: HADJOD, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | HIFENAC P | BID AFTER FOOD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Mandibular fractures
patient who is willing to participate in the study |
|
| ExclusionCriteria |
| Details |
patient with systemic disorders
immunocompromised patients
mentally challenged patients
pregency and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
biochemical paramters
radigraphic assessment |
day 0
day 7
day 21
day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pain
swelling |
day 0
day 7
day 21
day 42 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
23/12/2026 |
| 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="3"
Months="0"
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
|
This is a single blinded randomized trial study planned to be conducted among the patients reporting to the Department of Oral and Maxillofacial surgery for mandibular fracture fixation. The nature and purpose of the study is explained to the participants. Informed consents will be obtained before starting the study. The objective of the study is to compare the reduction in pain, swelling and bone healing while using cissus quadrangularis capsule following mandibular fractures. Sample size is calculated to be 52. Pain, swelling , biochemical parameters and radiographic assessment between two groups will be compared by using t test. |