Skip to content

Clinical study to evaluate the effect of Sadabahar extract in the management type 2 Diabetes mellitus

Double Blind,Placebo Controlled Evaluation of Adjuvant Effect of Whole Plant Ethanol Extract of Sadabahar (Vinca rosea Linn.)in Prameha with special reference to type 2 Diabetes Mellitus. - NA

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057588
Enrollment
62
Registered
2023-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Sponsors

Dean and Principal of Faculty of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Known case of Type 2 Diabetes Mellitus and on medication showing symptoms of Prameha. Patients with FBS more than 125mg/dl to 300 mg/dl and PP2BS more than 140mg/dl to 400mg/dl (both are inclusive).Patients with HbA1C levels between 7.0 to 10mg%.

Exclusion criteria

Exclusion criteria: 1.Patients having FBS more than 300mg/dl,PP2BS more than 400mg/dl and HBA1C more than 10mg%. 2.Patients showing acute complications and chronic complications-neuropathy,nephropathy,ratinopathy. 3.Patients with Diabetes Mellitus type 1. 4.Patients with other systemic diseases-IHD, uncontrolled hypertension. 5.Lactating and Pregnant women. 6.Known case of immuno compromised condition-HIV. 7.Known case of Active Infectious Disease.

Design outcomes

Primary

MeasureTime frame
Assessment on the basis of gradation of classical symptoms of prameha i.e Daurbalya, Kshudha Vridhi, Pipasa Vriddhi,Mutra atipravruti, Nakta mutrata,Pindiko dvestana, Swedapravriti, Shwasa kastataTimepoint: on baseline visit, on screening visit, on 15th day, on 30th day, on 45th day, on 60th day,on 75th day,on 90th day.

Secondary

MeasureTime frame
Assesment on basis of objective parameters i.e FBS,PP2BS,HbA1C,Lipid profile, BMITimepoint: FBS & PP2BS - On baseline visit, 3oth day,60th day, 90th day. HbA1c,lipid profile on baseline visit and 90th day BMI -on baseline visit, on screening visit, on 15th day, on 30th day, on 45th day, on 60th day,on 75th day,on 90th day.

Countries

India

Contacts

Public ContactDr Vaishali S deshande

Parul Institute Of Ayurveda

dr.shaileshd@gmail.com9763104451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026