| CTRI Number |
CTRI/2026/02/104128 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to check the effectiveness of natural mouthwash made from guava leaves and lotus seeds in treating gum swelling and redness |
|
Scientific Title of Study
|
Antimicrobial effect of guava leaf(psiduim guajava) and lotus seed(Nelumbo nucifera) extract in mouth rinse as an adjunct in the treatment of chronic gingivitis- A 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 Haritha M |
| Designation |
Post graduate |
| Affiliation |
Karpaga vinayaga institute of dental sciences |
| Address |
3rd floor , Department of periodontology , Karpaga vinayaga institute of dental sciences, GST road , chinnakolambakkam, Maduranthagam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789902226 |
| Fax |
|
| Email |
harithaperio13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemalatha R |
| Designation |
professor and guide |
| Affiliation |
Karpaga vinayaga institute of dental sciences |
| Address |
3rd floor , Department of periodontology , Karpaga vinayaga institute of dental sciences, GST road , chinnakolambakkam, Maduranthagam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9884970030 |
| Fax |
|
| Email |
hemaarun21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemalatha R |
| Designation |
professor and guide |
| Affiliation |
Karpaga vinayaga institute of dental sciences |
| Address |
3rd floor , Department of periodontology , Karpaga vinayaga institute of dental sciences, GST road , chinnakolambakkam, Maduranthagam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9884970030 |
| Fax |
|
| Email |
hemaarun21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Haritha M |
Karpaga vinayaga institute dental sciences |
3rd floor , Department of periodontology , Karpaga vinayaga institute of dental sciences, GST road , chinnakolambakkam, Maduranthagam, kancheepuram, Tamil Nadu
603308
Kancheepuram
TAMIL NADU |
9789902226
harithaperio13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingivitis |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Hexidine | 0.2% cholrhexidine gluconate mouth wash | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: 0.2% nelumbo nucifera seed extract mouth wash , Reference: 0.2% lotus seed extract mouth wash , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: 0.2 % pisudium gujava extract mouth wash , Reference: 0.2 % guava leaf extract mouth wash , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Age ranging between 18 and 40 years
Presence of minimum 24 functional teeth
Presence of chronic generalized moderate to severe form of gingivitis
Patients within the age group of 18 to 45 years
|
|
| ExclusionCriteria |
| Details |
systemically compromised patients
subjects with removable or fixed orthodontics appliance or prosthesis
subjects who were prescribed antibiotics or inflammatory drugs in the past 3 months
patient on high polyphenol diet
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced microbial colony Forming unit (CFU) , plaque index , gingival index in guava leaf mouthwash group , lotus seed extract mouth wash group are expected |
At baseline , 4 weeks , 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced microbial colony Forming unit (CFU) in guava leaf and lotus seed group |
At 1 months= and 3 month |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
24/02/2026 |
| 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="0"
Months="3"
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
|
The study aims to evaluate the clinical efficacy of herbal extracts of Psidium guajava and Nelumbo nucifera in reducing dental plaque and gingival inflammation. The preparation begins with the extraction of bioactive compounds from dried guava leaves and lotus seeds using a hydroethanolic solvent. This extract is formulated into 0.5,0.10 ,0.15 ,0.2 concentrations. After MIC , concentration is standardised and mouth wash formulated with standardised concentration base , incorporating glycerin glycerol, propylene glycol , Tween 80 , menthol, and distilled
water. After initial phase of periodontal therapy , participants will be randomly assigned to either the test group and control group. The intervention involves rinsing with 5ml of solution for 60 seconds twice daily for one month . Evaluation is based on primary outcomes including the plaque index, the gingival index measured at baseline, one month and three month. Secondary outcomes will involve microbial analysis to determine the reduction in colony-forming units in saliva. |