Shalmali Ghrita and Nishakatakadi Ghanavati after Virechan Karma in Madhumehaja Klaibya (Diabetes Mellitus induced Erectile Dysfunction)

Phase 3

Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Registration Number: CTRI/2024/02/062500

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Male patient in the age group of 25-50 years

2 Patients giving a clinical history of erectile dysfunction and having IIEF - EF score of = 25

3 Patients giving a clinical history of diabetes (DM Type II) and or Fasting blood sugar (FBS) more than 126 mg per dl up to 180 mg per dl and or Postprandial blood sugar (PPBS) more than 140 mg per dl up to 300 mg per dl

4 Glycosylated hemoglobin (HbA1C) more than 6.5%, up to 12%.

5 Early-diagnosed cases are to be included as per the following criteria:

• Patient accidentally diagnosed in routine check-up or when appeared with other complaints in the hospital.

• Patients already taking conventional medicines or Ayurvedic medicine and who fall within the inclusive criteria mentioned above will be taken into group A (control) and B (trial) respectively (dose adjustment can be done).

• Early diagnosed diabetic patients (Maximum 5 years of diabetic history).

Exclusion Criteria

1.Patients having insulin-dependent DM (type 1) and receiving insulin

2.Emergency conditions in cases of DM.

3.Patients with acute or chronic liver disease with elevated liver enzymes.

4.Patients were reported being hypersensitive to any of the proposed trial drugs.

5.Participation in other clinical studies in the past 12 weeks.

6.Takes psychotropic medications that raise blood glucose (e.g., atypical antipsychotics)

7.Patients suffering from Uncontrolled Hypertension (more than 140 by 90mmHg), Hypothyroidism, Nephropathy, CAD (taking allopathy medication for same), and any other chronic comorbid condition.

8.Patients suffering from STD, Carcinoma, AIDS, TB, congenital abnormalities of genital organs, other diseases like Phimosis, Ulceration, Hydrocele, Spinal cord lesions, etc.

9.For any reason, the investigator may consider a subject inappropriate for participation in this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in IIEF – EF scoreTimepoint: Day 0, 8 Weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in <br/ ><br>1. Fasting Blood Sugar (FBS) <br/ ><br>2. Post Prandial Blood sugar level (PPBS) <br/ ><br>3. Glycosylated haemoglobin (in %) – HbA1CTimepoint: Day 0, 8 Weeks and 12 weeks for 1 and 2 and Day 0, 8 Weeks for 3