To study the effect Varadarvyadi Ghanavati in the management of Diabetes Mellitus.

A controlled clinical study to evaluate the efficacy of Varadarvyadi Ghana Vati as an adjuvant drug to metformin in the management of Prameha with special reference to Type 2 Diabetes Mellitus - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083524

Enrollment

Registered

2025-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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. Subjects who are willing to give written informed consent. 2. Patients having signs & symptoms of Prameha like Prabhutmutrata (Polyuria), Pipasadhikya (Polydipsia), Kshudhaadhikya (increased meals), Mutramadhurya (Glycosuria), Swedadhikya (Profuse sweating). 3. Patients having BSL (F) = 126 - 250 mg/dl (PP) = 250 - 350 mg/dl 4. HbA1c level = 6.5 - 10% 5. The patient of hyperglycemia along with clinical symptoms.

Exclusion criteria

Exclusion criteria: 1. Patient taking or requiring OHA other than metformin 2. Patient having IDDM, Juvenile Diabetes Mellitus, Gestational Diabetes Mellitus, diabetes with complications, Ketoacidosis, Drug induced Diabetes like use of glucocorticoid, thiazide diuretic etc. 3. Pregnant & lactating women 4. Hepatitis B, Hepatitis C, AIDS, Tuberculosis, CA or any other immunocompressive disorder and major life threatening diseases. 5. Patient with IHD, Kidney disease, CVA (Hemiplegia) 6. Patient on immunosuppressive therapy, on antidepressant agents, patient with hypothyroidism or hyperthyroidism. 7. Mentally retarded, Psychologically unstable and non-cooperative patients.

Design outcomes

Primary

Measure	Time frame
1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at 4th week, 6th week, 8th week, 10th week and 12th week. 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati with 12 weeks of duration 3) To study the effect of Varadarvyadi Ghanavati on BSL, HbA1c after 12 weeks.Timepoint: 1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at the time of 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati after 12th week. 3) To study the effect of Varadarvyadi Ghanavati on BSL, HbA1c after 12 weeks.	—

Measure

Time frame

1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at 4th week, 6th week, 8th week, 10th week and 12th week. 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati with 12 weeks of duration 3) To study the effect of Varadarvyadi Ghanavati on BSL, HbA1c after 12 weeks.Timepoint: 1) To study the effect of in Varadarvyadi Ghanavati the symptoms of Prameha like Prabhutamutrata (Polyuria), Pipasavruddhi (Polydipsia), Kshudhavruddhi(Increased Hunger), Mutramadhurya (Glycosuria), Swedadhikya(Profuse sweating) at the time of 2nd week, 4th week, 6th week, 8th week, 10th week and 12th week 2) To reduce the risk of IHD, Obesity, Hyperlipidemia with the use of Varadarvyadi Ghanavati after 12th week. 3) To study the effect of Varadarvyadi Ghanavati on BSL, HbA1c after 12 weeks.

—

Secondary

Measure	Time frame
1) To review the Ayurvedic & Modern literature on Type 2 Diabetes Mellitus. 2) To correlate Prameha vyadhi and Type 2 Diabetes Mellitus. 3) To asses the possible mode of action of Varadarvyadi Ghanavati.Timepoint: At 2nd, 4th, 6th, 8th, 10th and 12th week	—

Countries

India

Contacts

Public ContactDR MEENAKSHI SUBHASH REWDKAR KOLE

R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI

drmrevadkar@yahoo.com9757476325

Outcome results