Prameha(Diabetes) treatment by Haridradigana Basti and Haridradigana ghana Vati

Phase 2/3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2021/12/038908
• Lead Sponsor: Dr Varinder Singh

Brief Summary

Patients will be recruited from inclusion criteria

Objectives will be

1.   Toassess the  efficacy of  *HaridradiganaYoga Basti* with *Haridradigana GhanaVati* over objective parameters i.e. Blood sugar  levels (Fasting &Post Prandial),  Urine Sugar  level, HbA1c in Diabetes Mellitus Type II

2.    Toassess the  efficacy of Metformin overobjective parameters i.e.  Bloodsugar  levels (Fasting & PostPrandial),  Urine Sugar  level, HbA1c in Diabetes Mellitus Type II

To compare the  efficacy of *Haridradigana Yoga Basti* with *HaridradiganaGhana Vati* and   Metformin over  objective parameters i.e. Blood sugar  levels (Fasting & Post Prandial), UrineSugar  level, HbA1c  in Diabetes Mellitus Type II

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-11-24
• Study Start: 2022-01-15

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Patients with either sex having age between 20 -60 years 2.Patients recently diagnosed for uncomplicated NIDDM (type 2 diabetes) and having Fasting blood sugar level ≥126 mg/dl Post meal blood sugar level ≥140 mg/dl 3.HbA1c ≥ 6.57 4.Old cases of type-2 DM not taking any other anti-hypoglycaemic drugs.
• 5.Diabetic Patients suffering from Controlled Hypertension (Blood Pressure not more than ≥140 mmHg or an average Diastolic Blood Pressure not more than ≥90 mmHg) 6.Patients willing to give informed consent 7.Patient fit for Basti Karma as per the Ayurvedic classics.

Exclusion Criteria

1.Patients suffering from IDDM (Insulin dependent diabetes mellitus) & patient with Type -2 Diabetes on insulin therapy 2.Patients suffering from Juvenile Diabetes or Gestational diabetes (ICD – 10 criteria 024) 3.DM with complications e.g. Retinopathy, Nephropathy, neuropathy ,previous history of coma 4.Patients suffering from any current acute illness, uncontrolled hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief in clinical features associated with Diabetes Mellitus Type II(Prameha)	1/2 month(45 days)

Secondary Outcome Measures

Name	Time	Method
1 To assess the efficacy of Haridradigana Yoga Basti with Haridradigana Ghana Vati over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II	2 To assess the efficacy of Metformin over objective parameters ie Blood sugar levels (Fasting and Post Prandial) Urine Sugar level HbA1c in Diabetes Mellitus Type II

Trial Locations

Locations (1)

Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma Gandhi Ayurved College Hospital and Research Centre Salod(H) Wardha

🇮🇳Wardha, MAHARASHTRA, India

Dr Varinder Singh

Principal investigator

8054532704

vrehaan100@gmail.com