| CTRI Number |
CTRI/2025/10/096548 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the role of Khadira Twak Gargling in maintenance of Oral Hygiene. |
|
Scientific Title of Study
|
Evaluation of the Effect of Khadira Twak Kwatha Gandusha in Mukhaswasthya (Oral Hygiene): Randomized Controlled Clininical 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 Sneha Vivekanandan Kuttan |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved |
| Address |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj-Dhankawadi, Pune
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj-Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8767882339 |
| Fax |
|
| Email |
snehakuttan19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Menon |
| Designation |
Professor & HOD |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved |
| Address |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj-Dhankawadi, Pune
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj-Dhankawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8007283293 |
| Fax |
|
| Email |
sudeep.menon@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep Menon |
| Designation |
Professor & HOD |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved |
| Address |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj-Dhankawadi, Pune
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved, Department of Swasthavritta evum Yoga, Katraj-Dhankawadi, Pune
MAHARASHTRA
411043
India |
| Phone |
8007283293 |
| Fax |
|
| Email |
sudeep.menon@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed To Be University) College of Ayurved Department of Swasthavritta Evum Yoga OPD No.15 Katraj Dhankawadi Pune 411043 |
|
Primary Sponsor
Modification(s)
|
| Name |
Self |
| Address |
Bharati Vidyapeeth (Deemed To Be University), College of Ayurved,Department of Swasthavritta Evum Yoga, Katraj-Dhankawadi, Pune 411043 |
| Type of Sponsor |
Private medical 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 |
| Dr Sneha Vivekanandan Kuttan |
College of Ayurved and Hospital |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved and Hospital, Department of Swasthavritta evem Yoga OPD no. 15 ground floor Katraj-Dhankawadi Pune 411043
Pune
MAHARASHTRA |
8767882339
snehakuttan19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY), PUNE (INDIA) COLLEGE OF AYURVED PUNE-SATARA ROAD, PUNE-411043. INSTITUTIONAL ETHICS COMMITTEE [BV(DU)COA-IEC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants with poor oral hygiene which will be assessed using an Oral health questionnaire, Oral Debris Index(0-1) and OHAT (Oral Health Assessment Tool) (8-16) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Ashtang Hriday, Procedure details: The participants with concentrated mind and face slightly lifted up should be asked to hold the medicated liquid in his mouth without doing any movement inside. Participants should be advised not to drink the liquid and hold it until the mouth gets filled with oro-pharyngeal secretions (kapha) and watery discharge (jalasrava) appears from the nose (nasa) and the eyes (netra).Procedure done for 3-5 mins per day.)
(1) Medicine Name: Khadira Twak, Reference: Bhava Prakash, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Ashtang Hriday, Procedure details: The participants with concentrated mind and face slightly lifted up should be asked to hold the medicated liquid in his mouth without doing any movement inside. Participants should be advised not to drink the liquid and hold it until the mouth gets filled with oro-pharyngeal secretions (kapha) and watery discharge (jalasrava) appears from the nose (nasa) and the eyes (netra). Procedure done for 3-5 mins per day.)
(1) Medicine Name: Triphala, Reference: Bhava Prakash, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants willing to perform Gandusha procedure.
Participants with poor oral hygiene which will be assessed using an Oral health questionnaire, Oral Debris Index (0-1) and OHAT (Oral Health Assessment Tool) (8-16).
|
|
| ExclusionCriteria |
| Details |
Participants suffering with chronic oral disease, premalignant conditions.
Known case of Oral Cancer, Major Oral disease, Dental injuries, etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lower gradation of oral debris.
Lower gradation of OHAT scale.
|
Baseline,7th,15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in halitosis
Enhanced oral freshness and taste.
|
Baseline, 21st day |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In Ayurveda, Mukha Swasthya refers to the health and cleanliness of the oral cavity. Oral hygiene, traditionally emphasized in Ayurvedic texts like Charaka Samhita and Ashtanga Hridaya, forms a part of daily health routines or Dinacharya. Regular oral care practices help prevent diseases of the mouth, throat, and even influence digestive and respiratory health. |