To find the difference between Mushkakadigana enema followed by Mushkakadigana tablet versus Tablet Metformin in the treatment of diabetes

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2023/10/059281
• Lead Sponsor: Mahatma gandhi ayurved college hospital and research centre hirapur salod wardha

Brief Summary

the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done.After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a parallel group, randomized, open clinical, standard controlled trial. it will include a 8 days treatment period and at 9th 24th and 45 day follow up period

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-11
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

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

Inclusion Criteria

1 Diabetic Patients willing to give written informed consent 2 Patient with either sex having age between 20 to 60 years 3 Patients recently diagnosed for uncomplicated NIDDM type two diabetes less then 6 month and having Fasting blood sugar level greater than 100 to 125 mg per dl Post meal blood sugar level greater than 140 to 300 mg per dl 4 Patients with and old cases of type two DM not taking any other anti-hypoglycemic drugs 5 Diabetic Patients suffering from Controlled Hypertension Blood Pressure not more then 140 mmHg or an average Diastolic Blood Pressure not more than 90mmHg 6 Patient fit for Basti Karma as per the Ayurvedic classics.

Exclusion Criteria

1 Patients suffering from IDDM Insulin dependent diabetes mellitus and patient with Type two Diabetes patient on insulin therapy 2 Patients suffering from Juvenile Diabetes or Gestational diabetes ICD 10 criteria 024 3 Impaired glucose tolerance ICD 10 criteria R73.0 4 DM with complications Retinopathy Nephropathy neuropathy previous history of coma 5 Patients suffering from any current acute illness uncontrolled hypertension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the efficacy of Mushkakadigana Yoga Vasti followed by Mushkakadigana Vati Versus Standard treatment Tab Metformin in the Blood sugar levels Fasting and Post prandial and	8 days
Urine Sugar Level	8 days

Secondary Outcome Measures

Name	Time	Method
to assess the efficacy of Mushkakadigana Yoga Vasti followed by Mushkakadigana Vati Versus Standard treatment Tab Metformin in the management of prameha type two Diabetes mellitus	1 week 1 day

Trial Locations

Locations (1)

Mahatma Gandhi Ayurved College Hospital and Research Centre; 🇮🇳 Wardha, MAHARASHTRA, India

Mahatma Gandhi Ayurved College Hospital and Research Centre

🇮🇳Wardha, MAHARASHTRA, India

Dr Vivek Goswami

Principal investigator

7000740949

vuniversal5@gmail.com