A clinical study to evaluate the efficacy and safety of Nisha-Amalki capsules in preventing progression to Diabetes in patients with Pre-Diabetes

Phase 4

Not yet recruiting

• Conditions: Pre-diabetic condition

• Registration Number: CTRI/2018/08/015503
• Lead Sponsor: PHARMANZA HERBAL PVT LTD

Brief Summary

Prediabetes, typically defined as blood glucose levels abovenormal but below diabetes thresholds, is a risk state that defines a highchance of developing diabetes. Diagnostic criteria for prediabetes have changedover time and currently vary depending on the institution. According to theWorld Health Organization (WHO), high risk for developing diabetes relates totwo distinct states, impaired fasting glucose (IFG) defined as fasting plasmaglucose (FPG) of 6.1–6.9 mmol/L (in the absence of impaired glucose tolerance –IGT) and IGT defined as postload plasma glucose of 7.8–11.0 mmol/L based on 2-horal glucose tolerance test (OGTT) or a combination of both. TheAmerican Diabetes Association (ADA), although applying the same thresholds forIGT, uses a lower cut-off value for IFG (FPG 5.6–6.9 mmol/L) and hasadditionally introduced HbA1c levels of 5.7–6.4% as a new category of highdiabetes risk.

Prediabetes, also known as intermediate hyperglycemia, is ahigh-risk state for diabetes. About 5–10% of people per year with prediabeteswill progress to diabetes, with the same proportion converting back tonormoglycemia. The worldwide prevalence of prediabetes is increasing andexperts have projected that more than 470 million people will have prediabetesby the year 2030. Prediabetes is associated with the simultaneouspresence of insulin resistance and β-cell dysfunction—abnormalities that startbefore glucose changes are detectable. Those individuals suffering frompre-diabetes may often suffer from hyperlipidaemia, hypertension and insulinresistance linked obesity obesity—all factors that sharply increase the risk ofheart disease.Observational evidence shows associations of pre-diabeteswith early forms of nephropathy, chronic kidney disease, small fibre neuropathy,diabetic retinopathy, and increased risk of macrovascular disease.

Multifactorial risk scores could optimize the estimation ofdiabetes risk using non-invasive parameters and blood-based metabolic traits inaddition to glycaemic. One of such score is Indian Diabetes Risk Score (IDRS).IDRS score was developed using four simple parameters namely age, abdominalobesity, family history of diabetes and physical activity. It is highly costeffective way of testing prediabetes in a resource poor setting like India.Higher IDRS is associated with higher risk of prediabetes, metabolic syndrome,CVD risk, etc.

Pre-diabetes is one of the major clinically entity, whichhave been vividly described in *Ayurvedic* classics in the context of *Prameha*striking resemblance with the available latest knowledge in this field. Lifestyleand dietary errors are the major etiological categories described for *Prameha*,which is closely resemblance with the etiology of Pre-diabetes. If leftuncontrolled for a prolonged duration, it may lead to *Madhumeha or* Diabetesmellitus.

The indigenous compound drug Nisha-amalaki selected forstudy is a combination of *Haridra(Curcuma longa)* and *Amalaki (Emblicaofficinalis)* as advocated by *Vagbhata*as a drug of choice for the treatment of *Prameha*.Based on the above hypothesis the present study has been undertaken to evaluatethe efficacy of *Nisha-amalaki* capsulesin patients with Pre-diabetes. Hence in the present study,we will be studying the efficacy, safety and tolerability of *Nisha-Amalaki*when given in an encapsulateddosage form to patients diagnosed withPre-diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-09
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Individuals fulfilling one or more laboratory criteria- Fasting blood sugar between 100-125 mg/dl, 2 hours glucose value between 140-199 mg/dl, IDRS (Indian Diabetics Risk score) less than or equal to 60.
• Those ready to give written informed consent.

Exclusion Criteria

• 1.Individuals with history of smoking, alcohol or tobacco addiction 2.Those with history of any major illness like hypertension, renal disorders, tuberculosis, epilepsy, neuropathies and psychiatric disorders.
• 3.Pregnant and lactating women.
• 4.Those who refused consent to participate in study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 1.Body weight	0 days and 180 days
2.BMI	0 days and 180 days
3.Fasting and PP Blood Sugar	0 days and 180 days
4.OGTT	0 days and 180 days
5.HbA1C	0 days and 180 days
6.Sr. Insulin	0 days and 180 days
7.Lipid profile	0 days and 180 days
8.Oxidative stress markers (MDA & SOD)	0 days and 180 days
9.C reactive protein for inflammation	0 days and 180 days

Secondary Outcome Measures

Name	Time	Method
1.Ayurvedic symptom Score for pre-Diabetes	2.Health related quality of life (HRQOL)

Trial Locations

Locations (1)

TN Medical College and BYL Nair Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

TN Medical College and BYL Nair Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Renuka Munshi

Principal investigator

2223027205

renuka.munshi@gmail.com