NCT01997814: Septilin

EFFECT OF SRP WITH ADJUNCTIVE THERAPY OF HERBAL IMMUNOMODULATORS ON THE SERUM C REACTIVE PROTEIN (CRP) LEVELS & CLINICAL PARAMETERS IN CHRONIC PERIODONTITIS PATIENTS - A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL TRIAL.

Completed Phase 4 Last updated 27 November 2013

What this trial tests

Phase 4 trial testing herbal immunomodulator in Chronic Periodontitis in 60 participants. Completed in 1 October 2013.

Timeline

1 March 2012

Primary endpoint
1 July 2013

1 October 2013

Quick facts

Lead sponsor	Tatyasaheb Kore Dental College
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2012
Primary completion	1 July 2013
Estimated completion	1 October 2013
Sites	1 location across India

Drugs / interventions tested

• herbal immunomodulator — full drug profile →
• Placebo

Conditions studied

• Chronic Periodontitis — all drugs for Chronic Periodontitis →

Sponsor

Tatyasaheb Kore Dental College

Who can join

Adults 30 to 55, any sex, with Chronic Periodontitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline in serum CRP levels at 3 weeks and 6 weeks
  Time frame: baseline, 3 weeks, 6 weeks
  changes from baseline in biochemical parameter, serum CRP levels were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. Serum CRP level was measured in milligram/liter (mg/l)
• changes from baseline in Pocket Depth (PD) at 3 weeks and 6 weeks.
  Time frame: baseline, 3 weeks and 6 weeks
  changes from baseline in standard clinical parameter, PD were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PD was measured in millimeters.
• changes from baseline in Clinical Attachment Level (CAL) at 3 weeks and 6 weeks.
  Time frame: baseline, 3 weeks and 6 weeks
  changes from baseline in standard clinical parameter, CAL were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PD was measured in millimeters.

Sponsor's own description

Addition of systemic herbal immunomodulators with scaling \& root planing (SRP) may enhance the therapeutic result of Chronic Periodontitis owing to host modulation \& anti-inflammatory properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Herbal anti-inflammatory immunomodulators as host modulators in chronic periodontitis patients: a randomised, double-blind, placebo-controlled, clinical trial.
   Deore GD, Gurav AN, Patil R, Shete AR, et al · · 2014 · cited 6× · PMID 24778901 · DOI 10.5051/jpis.2014.44.2.71