| CTRI Number |
CTRI/2026/01/101102 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An interventional trial to Compare and evaluate the efficacy of T.arjuna, a herbal product, with Tetracycline in treatment of Periodontitis |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF THE EFFICACY OF TERMINALIA
ARJUNA AND TETRACYCLINE DELIVERED LOCALLY AS AN ADJUNCT TO
SCALING AND ROOT PLANING A CLINICOBIOCHEMICAL 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 |
Pooja Yadav |
| Designation |
junior Resident |
| Affiliation |
Faculty Of Dental Sciences, Uttar Predesh University of medical sciences |
| Address |
Room no 426,Faculty Of Dental Sciences, Uttar Predesh University of medical sciences,Saifai,Etawah
Faculty Of Dental Sciences, Uttar Predesh University of medical sciences,Saifai ,Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8053583693 |
| Fax |
|
| Email |
poojayadav91695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
Professor |
| Affiliation |
Department of Periodontology, Faculty of dental sciences, UPUMS,SAIFAI, ETAWAH |
| Address |
Department of Periodontology, Faculty of dental sciences, UPUMS,SAIFAI, ETAWAH
Department of Periodontology, Faculty of dental sciences, UPUMS,SAIFAI, ETAWAH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
08449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
Professor |
| Affiliation |
Department of Periodontology, Faculty of dental sciences, UPUMS,SAIFAI, ETAWAH |
| Address |
Department of Periodontology, Faculty of dental sciences, UPUMS,SAIFAI, ETAWAH
Department of Periodontology, Faculty of dental sciences, UPUMS,SAIFAI, ETAWAH
UTTAR PRADESH
206130
India |
| Phone |
08449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pooja Yadav self funded |
| Address |
Village Dhani kumbhawas,Teh-Pataudi PIN-122413 Gurugram, Haryana |
| 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 Pooja Yadav |
Room no 426,Department of Periodontology,Uttar Pradesh University of Medical Sciences |
Saifai Etawah PIN 206130
Etawah
UTTAR PRADESH |
08053583693
poojayadav91695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Uttar Pradesh University of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: nil, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Terminalia arjuna, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: -nil), Additional Information: Terminalia arjuna gel ia locally administered in periodontal pockets after scaling | | 2 | Comparator Arm (Non Ayurveda) | | - | Tetracycline gel | 0.1 mg of tetracycline gel OD is locally delivered in periodontal pocket after scaling and root planing |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group- 18-50 years.
Patient with moderate chronic periodontitis.
Probing pocket depth 4-5 mm.
Systemically healthy patients. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women.
Smokers, Alcoholics
Patients who had undergone periodontal therapy in last 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
The present study expects more reduction in inflammation on
sites treated with T. arjuna gel as compared to tetracycline gel when locally delivered
as an adjunct to SRP in chronic periodontitis patients. |
Baseline,15 days,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
05/02/2026 |
| 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 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
|
Periodontitis is a chronic inflammatory disease of the periodontium caused by oral microbiota that destroy the periodontium to cause a possible tooth loss. The subgingival microbiota and immune inflammatory response of the host is responsible for triggering inflammation in periodontitis. The conventional treatment method, scaling and root planing remains primary non-surgical management of chronic periodontitis. Incorporation of systemic antimicrobial agents as an adjunct to SRP can provide improved outcomes than SRP alone. The use of locally delivered antimicrobials have various advantages over systemic administration. Tetracycline has been used to treat periodontal diseases due to its unique ability to reduce degradation of collagenous matrix by inhibiting the Matrix Metalloproteinases (MMPs). Many, studies have supported that novel drugs derived from herbs and certain plant extract improve periodontal health. Terminalia arjuna is one such plant. The bark extract of Terminalia arjuna shows antibacterial, anti-inflammatory and antioxidative activity even at low concentration. |