Diabetes treated by Homeopathy Medicine, Clinical report

This is a clinical trial report commissioned and published by SBL to validate the effectiveness of Diaboherb, a homeopathy medicine for treatment of Diabetes. It was conducted by Dr. Harisha.S, Kiran Vuppala of IC Bio Clinical Research Pvt. Ltd Bengaluru in coordination with Dr. Rajanna Muniswamappa, Bangalore Diabetic Centre and Dr. Beena Thomas (SBL Pvt Ltd).

Clinical Trial of Diaboherb (Poly Herbal Homeopathy Product) in the Treatment of Type 2 Diabetes Mellitus

Abstract

Background: Diabetes mellitus, often simply referred to as diabetes, is a group of metabolic diseases in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. This high blood sugar produces the classical symptoms of polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger) and myalgia.

Objectives: The aim of the study is to evaluate the safety and efficacy of Diaboherb in patients with type 2 diabetes mellitus.

Conclusion: “Diaboherb” (a poly herbal homeopathy medicine form SBL) is found effective in treating the type II diabetes patients with positive outcome on the quality of life like Polyuria (frequent urination), Polydipsia (increased thirst) and Polyphagia (increased hunger)and myalgia.

Keywords: Diaboherb, Fasting blood glucose, Post Prandial blood glucose and HbA1C.

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Introduction: Type 2 Diabetes

Diabetes Mellitus type 2 (formerly Non Insulin-Dependent Diabetes Mellitus (NIDDM) or adult-onset diabetes) is a metabolic disorder that is characterized by hyperglycemia (high blood sugar). Type 2 Diabetes Mellitus is characterized by insulin resistance, which may be combined with relatively reduced insulin secretion. The defective responsiveness of body tissue to insulin is believed to involve the insulin receptor. However, the specified defects are not known. Diabetes Mellitus cases due to a known defect are classified separately. Type 2 diabetes is the most common type. In the early stage of type 2, the predominant abnormality is reduced insulin sensitivity. At this stage, hyperglycemia can be reversed by a variety of measures and medications that improve insulin sensitivity or reduce sugar production by the liver. The classic symptoms are excess thirst, frequent urination, and constant hunger. Type 2 diabetes makes up about 90% of cases of diabetes, with the other 10 % due primarily to Diabetes Mellitus type 1 and gestational diabetes. Obesity is thought to be the primary cause of type 2 diabetes in people who are genetically predisposed to the disease.

The New break through – Diaboherb : This is a herbal health supplement which takes care of the complications associated with diabetes, i.e., polyuria, polydipsia, polyphagia, myalgia and complications of diabetes. The effectiveness of Diaboherb will help diabetic patient of (Type 2) by helping reduce complications which may lead to serious consequences. To control sugar levels effectively and to get remote from the complications of the diabetes, diaboherb plays a vital role.

Clinical Trial

” A prospective, randomized, double blind, placebo controlled clinical study to evaluate the efficacy and safety of Diaboherb in patients with Type 2 Diabetes Mellitus ”

Methodology

A prospective, randomized, double blind, placebo controlled proof of concept study enrolled 150 type II diabetic patients, who met the selection criteria.

Material and Method

Inclusion Criteria

Males and Females Patients with Type 2 Diabetes Mellitus with age 30-65 year.
Only new cases with inadequate glucose control.
Body mass index between 20-35 kg/m2
Having fasting blood glucose > 126 mg/dL.
Post prandial blood glucose > 200 mg/dL.
Having no serious Physical abnormalities other than those generally associated with type 2 Diabetes Mellitus.
Patient is willing and able to comply with all trial requirements.
Ability to understand the Informed Consent and Willing to Sign on informed consent along with audio video visual in accordance with GCP and local legislation.
Patients able to understand and follow the protocol of the trial.
Participants who are able to visit the medical institutions throughout the study period.

Exclusion Criteria

Patients having Insulin dependent Diabetes Mellitus.
Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs
Pregnant or lactating women
Patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug.
Previous participation in a clinical trial in the last 6 months. •

Subjects who are already taking or have taken in the past 2 months any investigational drug.

Dehydration by clinical judgment of the investigator.
Any contraindication to blood sampling.
Severe asthma that is poorly controlled with medication.

Ethics Committee Approval

All study related documents Protocol, CRF, Dairy Card, Investigator Brochure, SF-36 and ICF (English and Kannada versions). Written informed consent was obtained from the subject (s) before the start of the trial and after due approval from the Clinical Independent Ethics Committee for Ethics in Research, Bangalore.

END POINTS

Consistent with the primary study objectives, the following endpoints was assessed among study participants

Primary Endpoints

Changes in Diabetic Panel Investigations. Secondary End points • Incidence and rate of adverse events • Quality of life questionnaire before and after the treatment ( SF-36 HEALTH SURVEY)

Disposition of Subjects

Total of 150 subjects Drug A : Diaboherb 1(50 Subjects) Drug B:Diaboherb 2 (50 Subjects) Drug C: Placebo (50 Subjects)

Visit details

The patients were screened and enrolled. The enrollment day was considered as the base line data and the patient were asked to visit on: Day 10, Day 20, Day 30, Day 45, Day 60, Day 75 and Day 90.

STATISTICAL ANALYSIS

The data was analyzed with 5% significance level and 80% power for study using SAS. The two sample mean is assessed using paired t – test. The difference between the groups was assessed using One Way ANOVA. Following sets of data emerged that validates the hypothesis that homeopathy medicine effectively treats Diabetes

CLINICAL TRIAL RESULTS

Efficacy Analysis (For Drug A)

Fasting Blood Sugar (mg/dl)

Table. Fasting Blood Sugar (mg/d1)from screening to end of treatment.

DRUG – A
Screening Fasting Blood Sugar (mg/dl)	144.698
End of Treatment Fasting Blood Sugar(mg/dl	134.557
Reduction in mean	10.14
Percentage reduction in mean(%)	7.008

Post Prandial Blood Sugar (mg/di)

Table. Post prandial blood sugar(mg/dl) from Screening to end of treatment.

DRUG – A
Screening Postprandial Blood Sugar (mg/dl)	236.557
End of Treatment Postprandial Blood Sugar(mg/dl)	219.5436
Reduction in mean	17.0134
Percentage reduction in mean(%)	7.192

Glycated Hemoglobin (HBA1C)

Table: Glycated Haemoglobin (HBA1C) (%) from Screening to end of Treatment

DRUG – A
Screening Glycated 4 Hemoglobin (HbAlc)(%)	7.492
End of Treatment Glycated Hemoglobin (HbAlc)(%)	7.372
Reduction in mean	0.12
Percentage reduction in mean(%)	1.602

FBS, PP BS and HbAlc levels (Drug A)

Table. Mean Value of FBS, PPBS and HbA1c Levels

Visit

FBS (mg/dL)

PPBS (mg/dL)

HbAlc (%)

Screening

144.698

236.557

7.492

End of the treatment(Day -90)

134.557

219.543

7.372

P Value (For Drug A)

P Value of FBS, PPBS and HbAlc Levels

P-Value

FBS

PPBS

HbAlc (%)

P Value equals 0.0014

P Value is less than 0.0001

P Value equals 0.0270

Significance

Very statistically Significant

Extremely Statistically

Significant Statistically Significant

Quality of Life (for drug A)

The results collected have shown that the Drug A has improvement in the quality of life by the management of symptoms like fatigue, dry mouth, thirst (Polydipsia), excessive urination (Polyuria), hunger (Polyphagia) and myalgia.

Safety evaluation (for drug A)

No Adverse events were reported for Drug A

Efficacy Analysis (For Drug B)

Fasting Blood Sugar (mg/di)

Table. Fasting Blood Sugar(mg/dl) from Screening to End of Treatment.

DRUG – B
Screening Postprandial Blood Sugar (mg/dl)	144.723
End of Treatment Postprandial Blood Sugar(mg/dl)	134.277
Reduction in mean 10.446	10.446
Percentage reduction in mean (%)	7.218

Post Prandial Blood sugar(mg/dl)

Table:Post prandial blood sugar(mg/dl) from screening to end of treatment.

DRUG – B
Screening Post prandial blood sugar(mg/dl)	236.7095
End of Treatment Post prandial blood sugar(mg/dl)	219.0473
Reduction in mean	17.6622
Percentage reduction in mean(%)	7.462

Glycatd Haemoglobin (HBA1C) (%)

Table: Glycatd Haemoglobin (HBA1C) (%) from Screening to end of Treatment

DRUG – A
Screening Glycatd Haemoglobin (HBA1C) (%)	7.422
End of Treatment Glycated Hemoglobin (HbAlc)(%)	7.256
Reduction in mean	0.166
Percentage reduction in mean(%)	2.237

FBS, PPBS and HbAlc Levels (Drug B)

Table: Mean Value of FBS, PPB Sand HbA1c Levels

Visit

FBS (mg/dL)

PPBS (mg/dL)

HbAlc (%)

Screening

144.723

236.7095

7.422

End of the treatment (Day -90)

134.227

219.0473

7.256

P Value (For Drug B)

P Value of FBS, PPBS and HbAlc Levels

P-Value

FBS

PPBS

HbAlc (%)

P Value equals 0.0010

P Value is less than 0.0001

P Value equals 0.0157

Significance

Very statistically Significant

Extremely Statistically Significant

Statistically Significant

Quality of life (for drug B) :

Safety evaluation (for drug B)

No Adverse events were reported for Drug B

Efficacy Analysis (For Drug C)

Fasting Blood Sugar (mg/dl)

Table. Fasting Blood Sugar(mg/dl) from Screening to End of Treatment.

DRUG – C
Screening Postprandial Blood Sugar (mg/dl)	144.7067
End of Treatment Postprandial Blood Sugar(mg/dl)	138.113
Reduction in mean	6.5937
Percentage reduction in mean (%)	4.557

Post prandial Blood Sugar (mg/dl)

Table. Post prandial blood sugar(mg/dl) from Screening to end of treatment.

DRUG – C
Screening Postprandial Blood Sugar (mg/dl)	236.44
End of Treatment Postprandial Blood Sugar(mg/dl	226.76
Reduction in mean	9.68
Percentage reduction in mean (%)	4.094

Glycated Haemoglobin (HBA1C) (%)

Table: Glycated Haemoglobin (HBA1C) (%) from Screening to end of Treatment

DRUG – C
Screening Glycated Haemoglobin (HBA1C) (%)	7.49
End of Treatment Glycated Haemoglobin (HBA1C) (%)	7.44
Reduction in mean	0.05
Percentage reduction in mean (%)	0.67

FBS, PPBS and HbAlc levels (Drug C)

Table. Mean Value of FBS, PPB Sand HbA1c Levels

Visit

FBS (mg/dL)

PPBS (mg/dL)

HbAlc (%)

Screening

144.7067

236.44

7.49

End of the treatment(Day -90)

138.113

226.76

7.44

P Value (For Drug C)

P Value of FBS, PPBS and HbAlc Levels

P-Value

FBS

PPBS

HbAlc (%)

P Value equals 0.0627

P Value is less than 0.0635

P Value equals 0.3406

Significance

Significance Not quite statistically Significant

Not quite Statistically Significant

Not Statistically Significant

Quality of life (for drug C)

The results collected have shown that the Drug C has no improvement in the quality of life because there is no improvement in the symptoms like fatigue, dry mouth, thirst (Polydipsia), excessive urination (Polyuria), hunger (Polyphagia) and myalgia.

Safety evaluation (for drug C)

No Adverse events were reported for Drug C

Discussion & Conclusion

The total number of subjects analyzed in the study (Diabetes treated by Homeopathy medicine) is 150, of which 50 subjects were randomly assigned to the Drug A group, 50 subjects were randomly assigned to the Drug B group and 50 subjects to the Drug C group. The subjects were called for screening visit and were given the Informed consent and screening procedures were started. Once the subjects were screen passed, eventually the subjects were randomized into the group A (Diaboherbl), group B (Diaboherb 2) and Group C (Placebo Group). The blind was broken after Day – 90 when as per the protocol the trial ended.

All individuals, who were included in this study, were analyzed in this report.

The data obtained from the three groups was analyzed statistically using paired t-test. The data was compared between the Active Groups(GroupA,Group B) and Placebo Group (Group C)for the parameters including reduction in blood sugar levels (FBS,PPBS,HbAlc). From the data obtained, it was found that the investigational product Diaboherb was showing significant percentage of increase in reduction of Fasting Blood Sugar(FBS),Post Prandial Blood Sugar(PPBS) levels and HbAlc levels with no adverse effects, which was considered as an important parameter in diabetic controlling.

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