An Open-Label, Single-Arm, Single-Centered Clinical Study To Evaluate The Efficacy And Safety Of Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, And Sairub Heal Pain Balm In Type 2 Diabetic Patients With Peripheral Neuropathy

Saisa Medi LLP1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2025年2月3日最近更新: 2026年2月6日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 100
试验地点: 1
主要终点: The Glycemic Control

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

BACKGROUND & INTRODUCTION

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by hyperglycemia resulting from insulin resistance and impaired insulin secretion. Over time, uncontrolled diabetes can lead to systemic complications, including peripheral neuropathy, which affects approximately 50% of diabetic patients. Diabetic peripheral neuropathy (DPN) is associated with chronic pain, numbness, tingling sensations, and reduced quality of life. Additionally, uncontrolled hyperglycemia exacerbates nerve damage and systemic inflammation, compounding the challenges faced by patients.

Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, and Sairub Heal Pain Balm are proprietary Ayurvedic formulations designed to address both the systemic and localized complications of T2DM. These products aim to improve glycemic control, alleviate neuropathic symptoms, and enhance overall patient well-being.

PURPOSE OF THE STUDY

This study aims to evaluate the effectiveness and safety of Sairub Heal Diaba Care, Sairub Diaba Neuro Pain Oil, and Sairub Heal Pain Balm in managing diabetic peripheral neuropathy in patients with Type 2 Diabetes Mellitus. The primary goals are to assess improvements in glycemic control, reduction of neuropathic pain and symptoms, enhancement of quality of life, and confirmation of the safety of these Ayurvedic formulations.

Result of the study:

A total of 100 subjects with type 2 diabetes mellitus and peripheral neuropathy were enrolled in the study. Out of 100 enrolled subjects 98 completed the study and 2 subjects were lost to follow up.

The mean age of the participants was 37.2 years. Both male and female subjects were included in the study. The mean body mass index reduced from baseline to the end of study.

Primary Outcome Results

There was a significant improvement in glycemic control from baseline to end of study. Mean HbA1c levels reduced from 8.25 at baseline to 6.08 at Day 180. Fasting blood sugar levels reduced from 152.16 mg per dL at baseline to 129.69 mg per dL at Day 180. Random blood sugar levels reduced from 209.32 mg per dL at baseline to 164.12 mg per dL at Day 180.

Neuropathic pain intensity showed marked reduction during the study period. The mean Numeric Pain Rating Scale score reduced from 8 at baseline to 2 at Day 180. Neuropathic Pain Symptom Inventory scores showed improvement in spontaneous pain evoked pain sensory disturbances duration of pain and frequency of pain attacks from baseline to end of study.

Secondary Outcome Results

Quality of life assessed using SF 36 questionnaire showed improvement across all domains including physical functioning energy emotional well being social functioning pain and general health by the end of the study.

Sleep quality improved during the treatment period. The mean sleep interference score reduced from 8 at baseline to 2 at Day 180 indicating reduced pain related sleep disturbance.

Safety Results

The study products were well tolerated. No serious adverse events were reported during the study. All reported adverse events were mild and resolved without medical intervention. Laboratory parameters and vital signs remained within normal limits throughout the study.

Conclusion

The study demonstrated that Sairub Heal Diaba Care Sairub Diaba Neuro Pain Oil and Sairub Heal Pain Balm are safe and effective in improving glycemic control reducing neuropathic pain and improving quality of life in patients with type 2 diabetes mellitus and peripheral neuropathy.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 30.00 Year(s) 至 75.00 Year(s)（—）
性别: All

入选标准

•Male or female participants aged between 30 and 75 years.
•Participants with elevated fasting blood sugar levels greater than 126 mg/dl and random blood sugar levels greater than 140 mg/dl.
•Participants diagnosed with Type 2 Diabetes Mellitus (T2DM) according to the diagnostic criteria set by the World Health Organization (WHO).
•HbA1c levels greater than 7%.
•Diagnosis of peripheral neuropathy confirmed using the Douleur Neuropathique 4 (DN4) questionnaire.
•Pain intensity score greater than or equal to 4 on the Numeric Pain Rating Scale (NPRS) in the past week.
•Participants experiencing daily neuropathic pain for at least 6 months.
•Use of insulin therapy or oral hypoglycemic agents, other than metformin.
•Participants must have the ability and willingness to provide written informed consent.
•Participants must be willing to comply with the study protocol, which includes regular sublingual administration, fasting requirements, application of investigational products, and attending all scheduled study visits.

排除标准

•1.History of severe comorbid conditions, including: Cardiovascular diseases.
•Hepatic dysfunction.
•Renal dysfunction.
•Known hypersensitivity or allergic reactions to any ingredients in the investigational products.
•Pregnant or lactating women.
•Participation in any other clinical trial within 30 days prior to screening.
•History of neurological disorders unrelated to diabetic peripheral neuropathy, such as multiple sclerosis or stroke.
•Presence of mononeuropathy or other causes of neuropathy, including vitamin B12 deficiency, hypothyroidism, or alcohol-related neuropathy.
•Current or recent treatment with systemic corticosteroids, anticonvulsants, or antidepressants specifically for neuropathic pain management.
•History of severe psychiatric illnesses, including major depression, schizophrenia, or any other serious mental health conditions.
•Any other condition, at the discretion of the investigator, that may interfere with the conduct or interpretation of the study results, including but not limited to cognitive impairments or medical conditions that require ongoing management during the study.