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

A Prospective, Multi-Arm, Open-Label, Singl-Centre Clinical Study to Evaluate the Safety and Efficacy of Surabhi Saara in Patients with Diabetes, Varicose Veins, PCOD, Ulcers and Acidity - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061920

Enrollment

Registered

2024-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E109- Type 1 diabetes mellitus without complications Health Condition 2: E119- Type 2 diabetes mellitus without complications Health Condition 3: I832- Varicose veins of lower extremities with both ulcer and inflammation Health Condition 4: N701- Chronic salpingitis and oophoritis Health Condition 5: K131- Cheek and lip biting Health Condition 6: K219- Gastro-esophageal reflux disease without esophagitis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Meantime for clinical recovery as per clinical recovery criteria 2. Drop in random blood glucose level in the sample group at the end of medication 3.Symptomatic Relief based on Venous Clinical Severity Score and CEAP score 4.To improve the quality of life in subjects affected with varicose veins 5.Normal appearing of ovary confirmed by TV USG Timepoint: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.	—

Measure

Time frame

1. Meantime for clinical recovery as per clinical recovery criteria 2. Drop in random blood glucose level in the sample group at the end of medication 3.Symptomatic Relief based on Venous Clinical Severity Score and CEAP score 4.To improve the quality of life in subjects affected with varicose veins 5.Normal appearing of ovary confirmed by TV USG Timepoint: Evaluations are performed on Day 1,30,60,90,120,150,180,210 and 240.

—

Secondary

Measure	Time frame
1.Progress in the signs & symptoms based on the standard pattern will be applied before & after treatment. 2.Relief in acidity symptoms after administration of medication. 3.Assessment of safety. Timepoint: 1.Assessment will be done at Day 1 & Day 240. 2.Evaluations on Day 1,30,60,90,120,150 & 240 3.The patient will be monitored on Day 30,60,90,120,180 & 240	—

Countries

India

Contacts

Public ContactSathyavathi L M

Surabhi Pharmaceuticals

vijaykimtata.vk@gmail.com919816333352

Outcome results