| CTRI Number |
CTRI/2025/08/092959 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A research study to find out if gut health supplements can ease psoriasis (itchy and scaly patches on the skin )and improve quality of life in Indian patients
|
|
Scientific Title of Study
|
Effect of Synbiotic supplementation as an add on therapy on clinical severity and quality of life in Indian patients with psoriasis- A double blind randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHarshitha Vani |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College And Hospital |
| Address |
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
07305888494 |
| Fax |
|
| Email |
harshithavani.v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNishanthi.A |
| Designation |
Professor in Pharmacology Department |
| Affiliation |
Sri Manakula Vinayagar Medical College And Hospital |
| Address |
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8870328494 |
| Fax |
|
| Email |
drnishanthipharm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHarshitha Vani |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical College And Hospital |
| Address |
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
07305888494 |
| Fax |
|
| Email |
harshithavani.v@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107. |
|
|
Primary Sponsor
|
| Name |
DrHarshitha Vani |
| Address |
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107. |
| 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 |
| DrHarshitha Vani |
Sri Manakula Vinayagar Medical College And Hospital |
Department OF Pharmacology,
Second Floor,
College Block,
Sri Manakula Vinayagar Medical College And Hospital, Kalitheerthalkuppam, Madagadipet, Pondicherry, India -605107.
Pondicherry
PONDICHERRY |
07305888494
harshithavani.v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI MANAKULA VINAYAGAR MEDICAL COLLEGE AND HOSPITAL - ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Maltodextrin - 1 capsule given orally once a day for 8 weeks. |
| Intervention |
Synbiotic |
Each hard gelatin capsule contains:
lactobacillus acidophilus-700 MILLION, lactobacillus rhamnosus -400 MILLION, lactobacillus Casei-300 MILLION, lactobacillus Plantarum -300 MILLION, lactobacillus Bulgarious -300 MILLION, Bifidobacterium longum - 300 MILLION, Bifidobacterium Infantis - 300 MILLION, Bifidobacterium Breve - 300 MILLION, Streptococcus Thermophilus -400 MILLION, with fructooligosaccharides - 100Mg - 1 capsule given orally once a day for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients aged 18 to 60 years either gender.
-Clinically diagnosed with psoriasis and on stable treatment for the past 3 months.
-Willingness to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
-Patients requiring any change in the psoriasis medication during the study period.
-Patients with other autoimmune or chronic inflammatory skin diseases
-Patients on antibiotics, probiotics, prebiotics or synbiotic therapy within past 6 weeks .
-Patients with history of gastrointestinal diseases ( Eg. IBD ,celiac disease)
-Patients with severe comorbidity/ major systemic illness ( Eg. Uncontrolled diabetes, active malignancy)
-History of immunosuppressive drug consumption except topical steroids
-Pregnant and lactating women.
-Known or suspected allergy or intolerance to probiotics, prebiotics, dairy proteins or supplement excipients.
-Participation in another clinical trial within the past 30 days. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -To evaluate the effect of synbiotic supplementation as an add on therapy, on the clinical severity of psoriasis using PASI ( Psoriasis area severity index) score over an 8 week period. |
over an 8 week period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To assess the impact of synbiotic supplementation as an add on therapy, onthe quality of life on psoriasis patients using DLQI (Dermatology life quality index)
-To assess the patient safety and acceptability of synbiotic supplementation |
over an 8 week period. |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
31/08/2025 |
| 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 is a randomized, double-blind, parallel group clinical trial evaluating the effect of synbiotic supplementation as an add-on to standard of care in Indian patients with psoriasis. Participants will be randomly assigned into two groups: Group A will receive synbiotic supplementation once daily for 8 weeks along with standard treatment of care, while Group B will receive (placebo -maltodextrin) along with standard treatment of care. The synbiotic contains a blend of lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus Casei, lactobacillus Plantarum, lactobacillus Bulgarious Bifidobacterium longum, Bifidobacterium Infantis, Bifidobacterium Breve, Streptococcus Thermophilus, with fructooligosaccharides . The primary outcome is to evaluate the change in Psoriasis Area Severity Index (PASI) from baseline to week 8. Secondary outcomes include change in Dermatology Life Quality Index (DLQI) and assessment of safety and acceptability of synbiotic supplementation. |