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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes from baseline in Pocket Depth (PD) at 3 weeks and 6 weeks.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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),
- •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.
研究组 & 干预措施
Test Group
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.
干预措施: herbal immunomodulator (Drug)
Control Group
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.
干预措施: Placebo (Drug)
结局指标
主要结局
changes from baseline in Pocket Depth (PD) at 3 weeks and 6 weeks.
时间窗: 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.
Change from baseline in serum CRP levels at 3 weeks and 6 weeks
时间窗: 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 Clinical Attachment Level (CAL) at 3 weeks and 6 weeks.
时间窗: 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.
次要结局
- Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
- Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
- change from baseline in Plaque Index (PI) at 3 weeks and 6 weeks(baseline, 3 weeks and 6 weeks)
- Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 3 weeks and 6 weeks.(baseline, 3 weeks and 6 weeks)
研究者
GIRISH DEORE
Principal Investigator
Tatyasaheb Kore Dental College