To study the effect of Nisha-Amalaki Churna and Shilajeet Vati in Prameha (Pre-Diabetic)

A clinicopathological study on Prameha Purvarupa (Pre-Diabetic Condition) and its management with Nisha-Amalaki Churna and Shilajeet Vati - NACSV

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030660

Enrollment

Registered

2021-01-21

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: E139- Other specified diabetes mellituswithout complications

Interventions

Intervention1: Nisha-Amalaki Churna: Nisha-amalaki churna 3 gm twice daily, empty stomach for 30 days. Control Intervention1: Shilajeet Vati: Shilajeet Vati having (500mg) 1 vati Twice daily, empty st

Eligibility

Inclusion criteria

Inclusion criteria: 1. Both new and treated cases will be included. 2. Patients who fulfill the diagnostic criteria. 3. Patients age between 30-65 years. 4. Patients having fasting plasma glucose 100- 125 mg% 5. Patients having oral glucose tolerance 140- 200 mg% 6. Patients with HbA1c 5.7%-6.4% 7. Patients having symptoms of Prabhuta mutrata (frequency of micturition), pipasa (increased thirst), kshudha (excessive appetite), kara- pada daha (burning sensation in hand and feet), kara-pada suptata (numbness of hand and feet), sweda pravritti (excessive sweating), mukha shosha (dry mouth), mukha madhurya (sweetness in mouth), sheeta priyata (liking for cold things) madhura shukla mutrata (sweetness in urine). 8. Subject willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients age 65 years . 2. Patients having fasting plasma glucose > 125mg% 3. Patients having oral glucose tolerance > 200mg% 4. Patients with HbA1c 6.5% or more. 5. Patients having complications of diabetes like ketoacidosis, nephropathy, neuropathy, retinopathy, and diabetic wounds. 6. Patients having chronic, contagious infection disease such as active tuberculosis, hepatits B or C, or HIV 7. Pregnant and lactating females. 8. Patients having active metabolic or gastrointestinal disease that may interfere with nutrient absorption, metabolism, excretion, excluding diabetes. 9. Type-1 diabetes mellitus and Type-2 diabetes mellitus. 10. Any other patient considered not fit for trial.

Design outcomes

Primary

Measure	Time frame
To control the symptoms of Prameha PurvarupaTimepoint: To control the symptoms of Prameha Purvarupa	—

Secondary

Measure	Time frame
Nisha-amalaki churna is more effective than Shilajeet vati individually.Timepoint: 31 days	—

Countries

India

Contacts

Public ContactProf Dr Pradip Kumar Panda

Govt Ayurvedic College and Hospital Balangir

drpkpandanidan@rediffmail.com9437150643

Outcome results

None listed

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