Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Drug: herbal immunomodulator
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients within age group of 30 to 55 years. Systemically healthy individuals. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria Exclusion Criteria: Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy), Smoking, Chronic alcoholics, Pregnancy or lactation, Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013, Confirmed or suspected intolerance to herbal medicines, Periodontal therapy done within the january 2012 to Jun 2013.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Group<br>Patients in Test Group were given Herbal Immunomodulators (SeptilinTM) 2 tablets twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks. | Drug: herbal immunomodulator<br>* Patients in Test Group were treated with scaling and root planing (SRP) along with Herbal Immunomodulators (Septilin) therapy, 2 tablets twice daily for 3 weeks.<br>* Other names: Septilin (brand name);|
| Placebo Comparator: Control Group<br>Patients in Control Group were given placebo drug 2 tablets twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks. | Drug: Placebo<br>* Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in serum CRP levels at 3 weeks and 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) | baseline, 3 weeks, 6 weeks | 
| changes from baseline in Pocket Depth (PD) at 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. | baseline, 3 weeks and 6 weeks | 
| changes from baseline in Clinical Attachment Level (CAL) at 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. | baseline, 3 weeks and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, GI 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. GI has a scoring criteria specified by Silness & Loe, 1963. | baseline, 3 weeks and 6 weeks | 
| change from baseline in Plaque Index (PI) at 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, PI 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. PI has a scoring criteria specified by Loe & Silness, 1964. | baseline, 3 weeks and 6 weeks | 
| Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 3 weeks and 6 weeks. | changes from baseline in standard clinical parameter, OHIS 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. OHIS has a scoring criteria specified by Greene and Vermilion, 1964. | baseline, 3 weeks and 6 weeks | 
| Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, SBI 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. SBI has a scoring criteria specified by Muhleman's (1971). | baseline, 3 weeks and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herbal medicine,, Host modulation therapy,, Periodontitis,, Meta-analysis,, Scaling and root planing.