COMBINED EFFECT OF YASTYADI PRATISARANA & PANCAKSIRI VRIKSA KASAYA GANDUSA IN DIABETIC PERIODONTITIS-open label single arm study

Diabetic periodontitis is a chronic inflammatory condition with a bidirectional relationship with diabetes mellitus, contributing to worsening periodontal destruction and poor glycemic control. Conventional treatments such as scaling, chlorhexidine mouthwash, and surgical procedures have limitations including cost, side effects, and incomplete efficacy in diabetic patients. Previous clinical studies have shown that Yashtyadi Pratisarana and Pancaksiri Vriksa Kashaya Gandusa are effective in reducing pain, bleeding gums, discoloration of gums, halitosis, and microbial load, while improving plaque index, gingival bleeding index, and salivary pH in periodontitis, but there is a lack of studies in diabetic populations.

The present study aims to assess whether administration of Yashtyadi Pratisarana (Yastimadhu, Sarjakshara, Shunti and Saindhava curna with honey, 650 mg, applied twice daily for 2 minutes) followed by Pancaksiri Vriksa Kashaya Gandusa (70 ml, held in the mouth for 5 minutes twice daily) for one month can effectively reduce the clinical symptoms of diabetic periodontitis and restore normal oral flora as assessed by saliva culture. Eighteen patients aged 35–65 years with HbA1c >7, plaque index and gingival bleeding index grade 1–2, and chronicity less than 5 years will be enrolled from OPD and IPD of Amrita Ayurveda Hospital. Patients with systemic illnesses, smokers, alcoholics, pregnant or lactating women, and those with alveolar bone destruction or contraindications to Gandusa will be excluded.

The intervention will be given for 30 days with follow ups on day 45, 60, 75 and 90. Subjective parameters (pain, bleeding gums, discoloration of gums, loosening of teeth) and objective parameters (plaque index, gingival bleeding index, salivary pH, microbial load, HbA1c) will be assessed before and after treatment. Data will be analyzed statistically using Wilcoxon signed rank test and paired t test. Improvement in subjective and objective parameters will be considered as outcome. Informed consent will be obtained in local language, CTRI registration and IEC approval will be ensured, and rescue medications will be provided if required. Patients will be allowed to withdraw in case of adverse effects, worsening symptoms, or unwillingness to continue. Dropouts will include missed doses, non-compliance, adverse events, migration, or mortality. This study is expected to provide evidence for a safe, cost-effective Ayurvedic protocol in managing diabetic periodontitis and improving oral health outcomes in diabetic patients.