FindTrial
Sign In

To Study the effect of Nisha-amalaki as an adjuvant drug in uncontrolled Type II Diabetes mellitus

Study the effect of Nisha-amalaki (as an adjuvant drug) in uncontrolled Type II Diabetes mellitus â?? A pragmatic, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029806
Enrollment
80
Registered
2020-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Intervention1: Tab. Nisha-Amlaki with Standard Conventional treatment: Tab Nisha-Amlaki 500mg to 1 Gm. Will be decided on case to case basis as per clinical condition and response of the patient. Cont

Sponsors

Mahatma Gandhi Ayurved College Hospital and Research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Type2 DM and HbA1C between 7-10%

Exclusion criteria

Exclusion criteria: Known case of CHF, CKD, Cirrhosis of liver Pregnant and lactating mother Severely ill patient

Design outcomes

Primary

MeasureTime frame
1.To evaluate the effect of Nisha-Amalaki on HbA1c and Blood Sugar level of fasting and Post Meal 2.To evaluate the parameters reflecting Oxidative stress i.e MDA(Malondialdehyde) and SOD(Superoxide dismutase) assayTimepoint: 2 months—

Secondary

MeasureTime frame
1.To classify the patients as per their prakriti (by prakruti assessment scale) and sthula & krush pramehi( by BMI) during the study 2.To evaluate the effect on CBC, LFT and KFT on 0, 30 and 60th day and lipid profile on 0 and 60th day to observe any adverse drug reaction (ADR) during study.Timepoint: 2 months—

Countries

India

Contacts

Public ContactDr Rohit Arun Waskar

Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod(H), Wardha, Maharashtra

rohit9642@gmail.com7218182090

Outcome results

None listed

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