| CTRI Number |
CTRI/2026/02/102908 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Melatonin and Pilocarpine in improving salivary flow in patients with Sjogrens syndrome |
|
Scientific Title of Study
|
Comparison of efficacy of Oral Melatonin with that of Oral Pilocarpine in the management of hyposalivation associated with Sjogrens syndrome |
| 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 GEETHANJALI D |
| Designation |
Principal Investigator |
| Affiliation |
Tamil Nadu Government Dental College and Hospital,Chennai |
| Address |
Room no.107,Department of Oral Medicine and Radiology ,Tamil Nadu Government Dental College and Hospital, No 1 TNPSC Road, Park Town ,Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9659898568 |
| Fax |
|
| Email |
geethanjalidevarajm31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L KAYAL |
| Designation |
Professor |
| Affiliation |
Tamil Nadu Government Dental College and Hospital Chennai |
| Address |
Room no.107,Department of Oral Medicine and Radiology ,Tamil Nadu Government Dental College and Hospital, No 1 TNPSC Road, Park Town ,Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
8610508345 |
| Fax |
|
| Email |
dr.louiskayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GEETHANJALI D |
| Designation |
Principal Investigator |
| Affiliation |
Tamil Nadu Government Dental College and Hospital,Chennai |
| Address |
Room no.107,Department of Oral Medicine and Radiology ,Tamil Nadu Government Dental College and Hospital, No 1 TNPSC Road, Park Town ,Chennai
TAMIL NADU
600003
India |
| Phone |
9659898568 |
| Fax |
|
| Email |
geethanjalidevarajm31@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr GEETHANJALI D |
| Address |
Tamil Nadu Government Dental College and Hospital Chennai 600003 Tamil Nadu India |
| 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 GEETHANJALI D |
TAMIL NADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL |
Room no 107,Department of Oral Medicine and Radiology
Chennai
TAMIL NADU |
9659898568
geethanjalidevarajm31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TAMIL NADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M350||Sicca syndrome [Sjogren], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Melatonin in the management of hyposalivation associated with Sjogrens syndrome |
The study group will receive tablet melatonin 5 mg once a day for 2 weeks |
| Comparator Agent |
Oral pilocarpine in the management of hyposalivation in Sjogrens syndrome |
The control group patients will be given tablet pilocarpine 5 mg thrice daily for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who satisfy the characteristic features of Sjogrens according to American European Consensus Sjogrens syndrome classification criteria Both Primary and Secondary Sjogrens syndrome
Individuals within the age group of 20-60 years Both genders
Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
Not willing to participate in study
Clinically significant cardiopulmonary disease renal disease or gastrointestinal tract disease diabetes mellitus hypersensitivity to pilocarpine use clinically significant ocular disease
Lactating or pregnant women
Allergic patients, immunocompromised patients.
Past history of head and neck radiation treatment.
Acquired immunodeficiency syndrome (AIDS)
Current use of anticholinergic drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of tablet Melatonin with tablet Pilocarpine in management of hyposalivation associated with Sjogren’s syndrome. |
AT BASELINE 1 WEEK 2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhanced oral function,reducing dental caries,oral candidiasis |
At baseline,7thday,14th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
14/04/2026 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [geethanjalidevarajm31@gmail.com].
- For how long will this data be available start date provided 20-06-2025 and end date provided 20-06-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A randomized controlled study designed to compare the efficacy of oral melatonin with oral pilocarpine in the management of hyposalivation associated with Sjogrens syndrome. Patients in the age group of 20 to 60 years fulfilling inclusion and exclusion criteria are included in the study. Incisional lip biopsy will be done under local anesthesia and minor salivary glands are histopathologically examined. Sjogrens syndrome positive patients fulfilling the American European Consensus classification criteria are included. Patients in study group are given tablet melatonin 5mg once a day for two weeks and patients in control group are given tablet pilocarpine 5 mg thrice daily for 2 weeks. The unstimulated salivary flow rate, salivary PH, Schirmers lacrimal test are done at baseline,7thday,14th day for assessment. |