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

Phase 1

• Conditions: Health Condition 1: E139- Other specified diabetes mellituswithout complications

• Registration Number: CTRI/2021/01/030660
• Lead Sponsor: Esha Dhiman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

1. Patients age <30 years and >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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To control the symptoms of Prameha PurvarupaTimepoint: To control the symptoms of Prameha Purvarupa

Secondary Outcome Measures

Name	Time	Method
isha-amalaki churna is more effective than Shilajeet vati individually.Timepoint: 31 days