A Multi-Arm, Open-Label, Single-Centre Clinical Study to assess the Safety and Efficacy of Surabhi Saara in Patients with Diabetes, Varicose Veins, PCOD, Ulcers and Acidity
- Conditions
- Health Condition 1: K131- Cheek and lip bitingHealth Condition 2: N701- Chronic salpingitis and oophoritisHealth Condition 3: K219- Gastro-esophageal reflux disease without esophagitisHealth Condition 4: E109- Type 1 diabetes mellitus without complicationsHealth Condition 5: E119- Type 2 diabetes mellitus without complicationsHealth Condition 6: I832- Varicose veins of lower extremities with both ulcer and inflammation
- Registration Number
- CTRI/2024/01/061920
- Lead Sponsor
- Surabhi Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Arm A ( Diabetes )
1.Patients with Type 1 and Type 2 Diabetes
2.Cases which are already diagnosed and who are on other systems of medicine treatment will also be taken into consideration.
Arm B (Varicose Vein)
1.Patients with unilateral and bilateral varicose vein in the lower limbs
2.Diagnosed case of varicose vein in lower limb
Arm C (Polycystic Ovarian Disease)
1.Female patients of age between 20-35years
2.USG pelvis showing polycystic ovaries
3.Irregular menstrual cycle: Eight or fewer menstrual cycles in the past year or inter menstrual periods of 45 days or longer
Arm D (Mouth ulcers)
1.Patients with sores or erosion in the inner lining of mouth
2.Cases which are already diagnosed and who are on other systems of medicine treatment will also be taken into consideration.
Arm E (Acidity)
1.Patients exhibiting signs of Acidity (pH test is done to detect the same)
Arm A (Diabetes)
1.Pregnant and lactating mothers
2.Severe cases of Diabetes
Arm B ( Varicose Vein)
1.Patients with the bleeding disorders
Arm C (Polycystic Ovarian Disease)
1.PCOD cases with severe Systemic illness
2.Pregnant and lactating mothers
Arm D and Arm E (Mouth ulcers and Acidity)
1.Chronic alcoholics and Habitual Tobacco chewers
2.Subjects with chronic immune diseases like HIV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Meantime for clinical recovery as per clinical recovery criteria <br/ ><br>2. Drop in random blood glucose level in the sample group at the end of medication <br/ ><br>3.Symptomatic Relief based on Venous Clinical Severity Score and CEAP score <br/ ><br>4.To improve the quality of life in subjects affected with varicose veins <br/ ><br>5.Normal appearing of ovary confirmed by TV USG <br/ ><br> <br/ ><br>Timepoint: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.
- Secondary Outcome Measures
Name Time Method 1.Progress in the signs & symptoms based on the standard pattern will be applied before & after treatment. <br/ ><br>2.Relief in acidity symptoms after administration of medication. <br/ ><br>3.Assessment of safety. <br/ ><br> <br/ ><br>Timepoint: 1.Assessment will be done at Day 1 & Day 240. <br/ ><br>2.Evaluations on Day 1,30,60,90,120,150 & 240 <br/ ><br>3.The patient will be monitored on Day 30,60,90,120,180 & 240