| CTRI Number |
CTRI/2025/09/094988 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Mercurius Solubilis And Constitutional Homeopathic Medicine For Treating Bad Breath |
|
Scientific Title of Study
|
To Assess The Efficacy Of Mercurius Solubilis Vis A Vis Constitutional Homeopathic Medicine In Management Of Halitosis: A Prospective Single Blind RCT |
| 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 Vaibhav Rathod |
| Designation |
Pg Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Department of Postgraduate and Research Center Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8446258945 |
| Fax |
|
| Email |
vaibhav15373@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha V Jadhavrao |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Department of Postgraduate and Research Center Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9923003441 |
| Fax |
|
| Email |
neha.jadhavrao@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha V Jadhavrao |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth Deemed to be University Homoeopathic Medical College and Homoeopathic Hospital Department of Postgraduate and Research Center Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9923003441 |
| Fax |
|
| Email |
neha.jadhavrao@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed To Be University Homoeopathic Medical College And Hospital Katraj, Dhankawadi, Pune-411043, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr. Vaibhav Namdev Rathod |
| Address |
Bharati Vidyapeeth (Deemed to be University), Homoeopathic Medical College and homeopathic Hospital, Department of Postgraduate and Research Center, Pune, Maharashtra, India. 411043 |
| 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 Vaibhav Rathod |
BVDU Homoeopathic Medical College and Hospital , Dept. of postgraduate and Research Centre,Pune |
Bharati Vidyapeeth (deemed to be university) Homoeopathic Medical College And Homoeopathic Hospital, Dept Of Post Graduate and Research centre Pune-Bangalore Highway, Pune, MAHARASHTRA
Pune
MAHARASHTRA |
08446258945
vaibhav15373@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bharati Vidyapeeth (DTU) HMC, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R196||Halitosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic Medicine |
Treatment Group (Group B): patients who did not get relief after taking Merc sol for 30 days.
IHM in centesimal potency single dose will be given.
Route of administration-Orally
Medium to Higher potency will be given according to symptom similarity follow up will be taken for 14 days of medicine. 5 follow ups will be taken for the period of 3 months. |
| Intervention |
Mercurius solubilis 30C |
Dose- Mercurius Solubilis 30C potency,
twice daily (BD),
Rout of administration-Orally
for a period of 28 days.
(Group A) will consist of 52: Mercurius Solubilis 30c
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 40 years.
Diagnosed with Organoleptic scale and genuine halitosis based on clinical examination
(sniff test) and halimeter.
Duration of symptoms more than one month.
Willing to provide written informed consent.
Available for the duration of study and follow-up. |
|
| ExclusionCriteria |
| Details |
Pseudo-halitosis or halitophobia.
Halitosis due to known systemic diseases like uncontrolled diabetes, hepatic or renal failure.
History of recent dental procedures (within 1 month).
Use of antibiotics, antiseptic mouthwash, or probiotics within 2 weeks.
Known hypersensitivity to mercury compounds.
Pregnant and lactating women.
Mentally incapacitated individuals. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the improvement of halitosis by using Mercurius Solubilis.
2. To assess the effectiveness of constitutional homeopathic medicines in improving halitosis in cases that are not relieved by Mercurius Solubilis.
3. To evaluate and compare the efficacy of Mercurius Solubilis and constitutional
homoeopathic medicine in reducing the severity of halitosis in patients aged 18–40 years.
|
Follow-up is taken after 14 days of the medicine prescribed.for the Period of 3 months.
The improvement in the follow up will be assessed based on the details of
Organoleptic scale and halimeter.(halimeter range -more than 200 ppb)
The second prescription will be based on the results of the follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To reduce the social embarrassment caused to reduce the halitosis.
2. To assess the patient-reported symptoms using validated tools, such as organoleptic
scores.
3. To minimize the complaints of halitosis in frequency of oral infection, foul breath other
symptoms related to the oral cavities. |
Follow-up is taken after 14 days of the medicine prescribed. for the period of 3 months
The improvement in the follow up will be assessed based on the details of
Organoleptic scale & halimeter.(halimeter range -more than 200 ppb)
The second prescription will be based on the results of the follow up |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="1"
Months="6"
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 study is a randomized, single-blinded comparative clinical trial to study and prescribe
medicines in cases of halitosis. The duration of treatment is 3 months and will be done on 52 patients at BVDUHMC, Pune. The results of patients will be assessed by using organoleptic scale and halimeter before and after treatment.. |