| CTRI Number |
CTRI/2025/12/098944 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gandoosha (Oral Oil Retention Procedure) safety & efficacy on oral hygiene indices in Orodental Health. |
|
Scientific Title of Study
|
An evaluation of safety, Efficacy and Treatment Adherence of Gandoosha (Oral Oil Retention Procedure) on Orodental Health in apparently healthy adult population- An assessor blind exploratory Randomized Controlled Study |
| Trial Acronym |
(CCRAS-Gandoosha) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Govind Reddy |
| Designation |
Assistant Director Incharge |
| Affiliation |
RRAP CENTRAL AYURVEDA RESEARCH INSTITUTE, Mumbai, CCRAS, MINISTRY OF AYUSH, GOVERNMENT OF INDIA |
| Address |
Podar Medical Campus, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224947822 |
| Fax |
|
| Email |
drrgreddy68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Govind Reddy |
| Designation |
Assistant Director Incharge |
| Affiliation |
RRAP CENTRAL AYURVEDA RESEARCH INSTITUTE, Mumbai, CCRAS, MINISTRY OF AYUSH, GOVERNMENT OF INDIA |
| Address |
Podar Medical Campus, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224947822 |
| Fax |
|
| Email |
drrgreddy68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Govind Reddy |
| Designation |
Assistant Director Incharge |
| Affiliation |
RRAP CENTRAL AYURVEDA RESEARCH INSTITUTE, Mumbai, CCRAS, MINISTRY OF AYUSH, GOVERNMENT OF INDIA |
| Address |
Podar Medical Campus, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224947822 |
| Fax |
|
| Email |
drrgreddy68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences under Ministry of Ayush |
|
|
Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES Ministry of AYUSH, Government of India |
| Address |
Janakpuri, New Delhi, India. |
| Type of Sponsor |
Other [Central Council for Research in Ayurvedic Sciences under Ministry of Ayush] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Dhoble |
Indian Dental Association |
IDA Head Office, DGP House, Prabhadevi, Mumbai – 400025
Mumbai
MAHARASHTRA |
9820094499
ashokdhoble@ida.org.in |
| Dr R Govind Reddy |
RRAP Central Ayurveda Research Institute, Mumbai |
Podar Medical Campus, Worli, Mumbai
Mumbai
MAHARASHTRA |
02224947822
drrgreddy68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE Dr. A. P. J. Abdul Kalam, Education, Research & Incubation Center and Super Speciality Dental Clinic Indian Dental Association Initiative |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Adults of age group from 18 to 60 years of all genders with Poor orodental hygiene with Simplified Oral Hygiene Index (OHI-S)- 3 to 6 |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: Aṣṭāṅga Hṛdaya – Sūtrasthāna 22 (Dinacharya Prakaraṇa), Procedure details: The procedure involves holding the sesame oil in the mouth (without gargling) Minimum 5 mins or till Gandoosha Siddhi laskshanas i.e. until eyes & nose show mild secretions, then spitting it out.)
(1) Medicine Name: Tila Taila, Reference: Ayurvedic Pharmacoepia of India , Route: Oral, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Orodental routine care | Routine dental hygiene includes toothbrushing with toothpaste twice daily, gargling after meals, and use of mouthwash to prevent plaque formation and maintain normal salivary bacterial count. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently Healthy Adults of age group from 18 to 60 years of all genders
2.Apparently Healthy Adults with or without removable or fixed prostheses or fixed and removable orthodontic appliances will be included.
3.Poor orodental hygiene with Simplified Oral Hygiene Index (OHI-S)- 3 to 6
|
|
| ExclusionCriteria |
| Details |
1.Population with uncontrolled systemic comorbidities like DM, HTN, IHD from available reports & ongoing medication record
2.Population with significant orodental pathology
3.Oral carcinoma in situ.
4.Oral premalignant conditions like- Erythroplakia, leukoplakia, OSMF (Screened participants with cancerous, precancerous lesions will be referred to Tata Memorial Hospital for further evaluation and management)
5.Use of antibiotics and anti-inflammatory drugs in previous one month
6.History of mouth rinses, gels or chewing gums use, that contain antimicrobial agents in the preceding one month
7.Chronic users of tobacco products (for more than three years) in its various forms
8.Participants with a history of regular or recent inhalation of corticosteroids
9.Allergy to any ingredient used in the study
10.Oral pathology that is interfering with the conduction of Gandoosha procedure- like OA/RA of TM joint
11.Participants with already a habit of practicing Gandoosha with any liquid
12.Pregnant or lactating females
13.Participants with hampered cough reflex |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Salivary Microbiome Profiles (Day 0 and Day 21)
2. Simplified Oral Hygiene Index (OHI-S) (Day 0 and Day 21) |
Day 0 and
Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Status of orodental health assessed on the basis of WHO Oral Health Assessment form- Adults
2. Change in existing orodental clinical signs and symptoms, if present (E.g.- tastelessness, halitosis, dental pain, sensitive tooth, mouth ulcers, gingival pain, bleeding etc.)
3. Safety profile assessed by incidence of AEs/ADRs
4. Treatment adherence will be assessed through the MARS-5 questionnaire. |
Day 0 and
Day 21 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2026 |
| 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
|
An assessor-blind randomized controlled trial is proposed in order to evaluate and establish the safety, tolerability, and efficacy of Gandoosha (Oral Oil Retention Procedure) on orodental health in the context of healthy oral condition in the apparently healthy adult population. Apparently, Healthy adult individuals will be randomized into two groups. The treatment group will undergo Gandoosha procedure with Murchita Sesame oil plus routine self-orodental healthcare practices and control group will undergo only routine self-orodental healthcare practices for 21 days. All the participants will be assessed before, during, and after interventions for changes in oral microbial count, dental plaque index, gingival index, and various symptoms like halitosis, tastelessness in healthy individuals, and also for conditions like mouth ulcers, halitosis, and dental caries. Along with efficacy, safety, and tolerability and adherence to the Gandoosha procedure will also be studied. |