| CTRI Number |
CTRI/2025/11/097321 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Co relating disease markers of periodontitis with psoriasis |
|
Scientific Title of Study
|
INSIGHTS INTO FIBRINOGEN LIKE PROTEIN 1
AND ELAFIN IN PERIODONTAL DISEASE AND
PSORIASIS SEVERITY |
| 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 Jammula Surya Prasanna |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE |
| Address |
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL
SCIENCES AND RESEARCH CENTRE, Department of Periodontics, room number 101. ROAD NO-5, KAMALANAGAR, DILSUKHNAGAR, HYDERABAD.
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL
SCIENCES AND RESEARCH CENTRE, Department of Periodontics, room number 101. ROAD NO-5, KAMALANAGAR, DILSUKHNAGAR, HYDERABAD.
Hyderabad
TELANGANA
500060
India |
| Phone |
9440387830 |
| Fax |
|
| Email |
surya.prasanna@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jammula Surya Prasanna |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE |
| Address |
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL
SCIENCES AND RESEARCH CENTRE, Department of Periodontics, room number 101. ROAD NO-5, KAMALANAGAR, DILSUKHNAGAR, HYDERABAD.
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL
SCIENCES AND RESEARCH CENTRE, Department of Periodontics, room number 101. ROAD NO-5, KAMALANAGAR, DILSUKHNAGAR, HYDERABAD.
Hyderabad
TELANGANA
500060
India |
| Phone |
9440387830 |
| Fax |
|
| Email |
surya.prasanna@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B N Srinivasa Sai Suman |
| Designation |
Post Graduate |
| Affiliation |
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE |
| Address |
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL
SCIENCES AND RESEARCH CENTRE, Department of Periodontics, room number 101. ROAD NO-5, KAMALANAGAR, DILSUKHNAGAR, HYDERABAD.
PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL
SCIENCES AND RESEARCH CENTRE, Department of Periodontics, room number 101. ROAD NO-5, KAMALANAGAR, DILSUKHNAGAR, HYDERABAD.
Hyderabad
TELANGANA
500060
India |
| Phone |
8639280509 |
| Fax |
|
| Email |
srinivasasaisuman@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
B N SRINIVASA SAI SUMAN |
| Address |
Room No. 101, Department of Periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre, Road No. 5, Kamalanagar, Dilsukhnagar, Hyderabad. |
| Type of Sponsor |
Other [POST GRADUATE] |
|
|
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 |
| B N SRINIVASA SAI SUMAN |
BRKR GOVERNMENT AYURVEDIC COLLEGE |
Department of Skin disorders, room number 8, Ground floor, ESI colony, Hyderabad- 500045
Hyderabad
TELANGANA |
08639280509
sumanbudithi2227@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B N SRINIVASA SAI SUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Elafin |
Elafin is an epithelial protein that is secreted by keratinocytes during inflammation and numerous studies have found that serum elafin levels are significantly higher in patients with psoriasis which demonstrates its correlation with the severity of the disease
|
| Comparator Agent |
Fibrinogen like protein 1 |
Fibrinogen-like factor 1 is a protein secreted by the liver that has been shown to function as an immunosuppressive agent in regulating the immune system and research suggests that FGL1 may serve as a novel marker that negatively correlates with the severity of psoriasis indicating the inverse relationship with psoriasis
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with known history of psoriasis with more than 14 teeth present in the oral cavity aged 25 to 65 years |
|
| ExclusionCriteria |
| Details |
Any other skin lesions/ diseases/ allergies other than psoriasis.
Uncooperative patients with respect to different
complications of psoriasis.
Mentally and Physically challenged patients.
Pregnant and lactating women.
Patients who have undergone periodontal treatments within
the past 6 months.
Patients receiving other medications.
Patients with other systemic diseases/ any uncontrolled severe diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
How do fibrinogen-like protein 1 (FGL1) and elafin levels correlate with serverity of psoriasis and periodontitis?
|
Initial Observation only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Is there a correlation between the clinical parameters of periodontitis & the severity of psoriasis
|
Initial Observation only |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
03/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/01/2026 |
| 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 Yet Recruiting |
| 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
|
Periodontitis is a chronic inflammatory disease that affects the tooth supporting tissues. It is now recognized as a significant risk factor for various systemic diseases, including psoriasis, which is gaining attention.
Fibrinogen-like factor 1 (FGL1) is a protein secreted by the liver that has been shown to function as an immunosuppressive agent in regulating the immune system. Research suggests that FGL1 may serve as a novel marker that negatively correlates with the severity of psoriasis, indicating the inverse relationship with psoriasis.
Elafin is an epithelial protein that is secreted by keratinocytes during inflammation. Numerous studies have found that serum elafin levels are significantly higher in patients with psoriasis which demonstrates its correlation with the severity of the disease.
Since psoriasis and periodontitis are both immune-mediated inflammatory conditions, this study aims to explore the relationship between biomarkers such as Fibrinogen-like Protein 1 (FGL1) and Elafin and their potential role in the pathogenesis of periodontitis.
|