Roll of nishakathakadi kashay in diabetes mellitus

Evaluation of nishakathakadi kashay as an anti-diabetic agent – a single arm clinical trial in type 2 diabetes mellitus patients with secondary failure to oral hypoglycemic agent w. s. r. to Prameha - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/057067

Enrollment

Registered

2023-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed patients of T2DM 2. Patients falling in the age group of 30-65 yrs. 3. Patients of irrespective gender will be included & who are willing to take medicine. 4. Failure to respond to OHA even in maximal doses of combination therapy. i.e. Metformin 1500mg/ Gliclazide 320mg/ Glimepride6-8mg / Glipizide 20mg / Pioglitazone 45mg/ Glibenclamide 45mg. Combination of the above drugs. 5. BSL- Fasting Range 130 mg/dL to 250 mg/dL 6.BSL –PP- Range170 mg/dL to 300 mg/dL 7.HbA1c – Range 6.5% to 10%

Exclusion criteria

Exclusion criteria: 1.K/c/o acute complications like Keto acidosis, Diabetic coma, acute infections of any part of the body, and Gangrene. 2. Diagnosed patients of T1DM 3. Pregnancy and lactating mother. 4. Patients on insulin and steroid therapy. 5. Patients with any major systemic diseases like Carcinoma, TB, and Immunocompromised patients or uncontrolled Hypertension. 6.K/c/o Neuropathic ulcer, Peripheral vascular disease, cardiovascular disease. 7. BSL fasting above 250 mg/dL will be excluded 8. PP above 350 mg/dL will be excluded 9.HbA1c above 10% will be excluded

Design outcomes

Primary

Measure	Time frame
Primary outcome will measure the effect of Drug All symptoms & blood values e.g. BSL fasting/PP, HbA1c, C-peptide valueTimepoint: Primary outcome will measure the effect of Drug All symptoms on Monthly basis & blood values e.g. BSL fasting/PP At baseline & At the end of every months for 6 Month. HbA1c will be measure at baseline, at the end of 3rd month & at the end of 6th month. And C-peptide value will be measure at baseline & at the end of trial i.e.6th month	—

Measure

Time frame

Primary outcome will measure the effect of Drug All symptoms & blood values e.g. BSL fasting/PP, HbA1c, C-peptide valueTimepoint: Primary outcome will measure the effect of Drug All symptoms on Monthly basis & blood values e.g. BSL fasting/PP At baseline & At the end of every months for 6 Month. HbA1c will be measure at baseline, at the end of 3rd month & at the end of 6th month. And C-peptide value will be measure at baseline & at the end of trial i.e.6th month

—

Secondary

Measure	Time frame
Secondary outcome is to observe the side effect of Oral Hypoglycemic drugs such as Anorexia, Feeling dizzy, feeling constipated, abdominal discomfort.Timepoint: Secondary outcome will be measure at baseline & at the end of every month for 6 months.	—

Countries

India

Contacts

Public ContactDr Pravin Gopinath Jagtap

Ayurved Mahavidyalaya & Shri Eknath Rugnalaya. Shevgaon,

sbhagwat.2007@rediffmail.com9890902106

Outcome results