Clinical study of Nisha Amalaki extract in Prediabetic with special reference to Prameha.

Phase 4

Not yet recruiting

Conditions: Metabolic disorders. Ayurveda Condition: PRAMEHAH, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHA-PURVARUPAM,

Registration Number: CTRI/2023/11/060110

Lead Sponsor: DR SAJIDA D ATTAR

Brief Summary: For the prevention of Diabetes specially type 2 diabetes and related complication it is a need to control this hyperglycaemia stage not only after diagnosis of type 2 diabetes mellitus but even before in prediabetes stage which is developed due to insulin resistance. Prediabetes is an intermediate step before manifestation of full blown DM. Prediabetes is an intermediate stage between normal and diabetes state wherein blood glucose levels are higher than normal but not high enough to be considered as diabetic.Prediabetes is a state of high risk for developing Diabetes with 5 to 10% cases converting to Diabetes per annum.This fact itself triggered the need of review of this disease. Prediabetes means a â€˜pre diagnosis of diabetesâ€™.Every third person who tested their blood sugar in Mumbai has prediabetes, according to a five-year data analysis of 2.9 lakh patients by a national laboratory. According to a study published in the Indian Journal of Medical Research in 2018, the estimated prevalence of prediabetes in India is 14% - and thatâ€™s just those who have been tested .Effective intervention at prediabetic step would help stop/slow progression to DM..

As the name suggests, prediabetes is a precursor or an early warning system to diabetes. Various herbs mentioned in the Ayurveda literature have been found to be useful for reduction in blood sugar, decrease in insulin resistance, and improvement in beta cell activity .Etiology of diabetes is multifactorial and multi targeted herbal drugs would be comparatively safer than modern drugs and may be used in management of prediabetes and prevention of progression to diabetes.Therefore, this study aimed to see whether Nishaamalaki can reduce the conversion from prediabetes to type 2 diabetes mellitus.

Combination of Nisha amalaki formulation has tridoshahara property but specically Kaphahara property. Its acts on vitiated Kapha, Meda and Kleda, It has capacity to improve tone of saptadhatus and reduces Dhatushaithilya. Due to its Deepan and Pachan properties, Dhatri nisha Churna works on Jatharagni and Dhatwagni, which reduces the Ama and kleda present in the body. It improves Dhatwagni which helps to improve disturbed metabolism. Nisha amalaki having Deepan, Pachan and Anuloman properties. By Deepan, Pachan, Anuloman properties it works on srotodushti and glucose metabolism. Due to its Ruksha Guna this kalpa is doing Kleda Shoshana which is useful in Samprapti bhanga of Prameha that is Prediabetic.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 124

Inclusion Criteria

1)Having IDRS score more than 50.
2)HbA1c level of 5.7-6.4% 3)A fasting blood Sugar level (FBS) of 110-125 mg/dL ; (fasting is done as no caloric intake for at least 8 hours.) 4)A 2-hour Blood Sugar level (PPBS) of 140 to 199 mg/dL .

Exclusion Criteria

1.Exclusion criteria included people currently usingÂ oral hypoglycemic agentsÂ (OHAs); those reporting prior use of medication to treat diabetes mellitus.
2.Type ll Diabetes Mellitus (NIDDM) 3.Type l Diabetes Mellitus (IDDM) 4.Subjects giving history of signicant cardiovascular event < 12 weeks prior to study 5.Subjects with known Chronic Infectious Disease, such as active Tuberculosis, Hepatitis B or C, or HIV.
6.Pregnant female and lactating mother.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy of Nisha Amalaki extract on symptoms of prediabetic as per subjective and objective assessment mentioned in synopsis	at every follow up 15th day, 30th day, 45th day, 60th day, 75 th day, 90th day

Secondary Outcome Measures

Name	Time	Method
To compare mode of action of nisha amalaki extract & tab metformin in management of prediabetis	to check safety or adverse effect of the drugs

Trial Locations

Locations (1): APMS AYURVED MAHAVIDYALA
🇮🇳
Mumbai, MAHARASHTRA, India
APMS AYURVED MAHAVIDYALA
🇮🇳Mumbai, MAHARASHTRA, India
DR SAJIDA D ATTAR
Principal investigator
8097061246
DR.SAJIDAATTAR@YAHOO.COM