To evaluate the efficacy of Vidangadi Ghanavati and Gokshuradi Guggulu after Virechana Karma versus Gabapentin in managing Pittavritta Madhumeha (Diabetic Neuropathy) in patients on conventional therapy

An open-label randomized controlled trial to evaluate the efficacy of Vidangadi Ghanavati and Gokshuradi Guggulu after Virechana Karma versus Gabapentin in managing Pittavritta Madhumeha (Diabetic Neuropathy) in patients on conventional therapy - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082237

Enrollment

106

Registered

2025-03-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Diabetic patients (DM Type II) who are already on antidiabetic medication (OHA) with signs and symptoms of Pittavritta Madhumeha (Diabetic Neuropathy) and fulfilling the diagnostic criteria Fasting blood sugar more than 126 mg/dl up to 200 mg/dl and Postprandial blood sugar more than 140 mg/dl up to 350 mg/dl. Glycosylated hemoglobin (HbA1C) more than 6.5% up to 12% Patients with up to 7 years of diabetic history. Patients willing to participate in the research study

Exclusion criteria

Exclusion criteria: Patients having disease like - diabetic nephropathy, ischemic heart disease, hereditary sensory and motor neuropathy (HSMN), leprosy, tuberculosis, bleeding disorder, psychiatric illness, inflammatory neuropathies. Patients having corticosteroids, anti-convulsants, anti-psychotics, anti-depressants, and anti-anxiety drugs. Patients suffering from hypothyroidism, hyperthyroidism and any other chronic comorbid condition (except hypertension). Patients with uncontrolled hypertension (more than 160/100 mm of Hg), and uncontrolled diabetes (fasting blood sugar level more than 200 mg/dl and postprandial blood sugar level more than 350 mg/dl) Pregnant women and lactating mothers. Patients were reported to be hypersensitive to any of the proposed trial drugs. Participation in other clinical studies in the past 12 weeks.

Design outcomes

Primary

Measure	Time frame
Improvement in vibration perception threshold, as measured by the neuropathy analyzer, at baseline and after 12 weeks of treatment in patients with Pittavritta Madhumeha (Diabetic Neuropathy).Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Improvement in Michigan Neuropathy Screening Instrument (MNSI) Change in Tactile sensation threshold and Thermal testing threshold. Relief in the cardinal signs and symptoms of Pittavritta Madhumeha (Diabetic Neuropathy). Improvement in overall QOL score as per the Norfolk QOL-DN Decrease in the level of HbA1C, FBS & PPBS Timepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Raja Ram Mahto

All India Institute of Ayurveda

drarchanashukla8@gmail.com7290907275

Outcome results