Benefits of participation in interventation of metabolic syndrome

Phase 2

Not yet recruiting

• Conditions: Other specified disorders of carbohydrate metabolism. Ayurveda Condition: MANDAGNIH/ AGNISADA,

• Registration Number: CTRI/2025/05/087732
• Lead Sponsor: State Ayurvedic College and Hospital Lucknow

Brief Summary

The Present Synopsis Entitled "A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF HERBAL COMPOUND WITH AND WITHOUT

VIRECHAN KARMA IN CASES OF DHATWAGNIMANDYA (W.S.R.TO METABOLIC SYNDROME)"



Aim :

1. To evaluate the clinical efficacy of herbal compound.

2. To evaluate the clinical efficacy of herbal compound after Virechana karma.

Objective:

1. To observe the disease Dhatwagnimandya clinically during the follow up period with and without the procedure.

2. To access the effectiveness of probable mode of action of herbal compound with and without virechan karma.

Plan of Study

For purpose of clinical trial, the patient of Dhatwagnimandya will be selected regardless of sex, religion ,socioeconomic status and occupation in the age group of 21-60 years from

OPD/IPD of State Ayurvedic college &Hospital, Lucknow and also the referred cases which fullfil the criteria.

After clinical examination ,history and lab investigation patients fulfilling the inclusion criteria and exclusion criteria will be enrolled for the clinical trial

Type of Study- Randomized parallel group study

Period of Study- Total duration of clinical trial will be of 3 months.

Follow up period without drug of Procedure- Follow up of all registered patients will be of one month without giving herbal compound and virechan karma procedure to assess the

condition of patients & to observe any side effect of procedure.



Inclusion criteria

1. Age- 21- 60 years

2. Fasting glucose 100 mg/dl- 140mg/dl

3. Blood Pressure 130/90 mm Hg-150/110mmHg

4. HDL 40mg/ dl -50mg/dl

5. Waist circumferance 90cm-110cm in men

80cm-100cm in women

6. BMI 25-40

7. Triglyceride 150mg /dl-200mg/dl

8. Patient having all essential criteria and minimum 50%nonessential criteria must be present for selection of cases

9. In the patients minimum 50% objective parameter must be present for selection of cases

10.Patient fit for virechan karma.

Exclusion criteria

1. Age group <2l years and > 60 years of age

2 Uncontrolled Diabetes Mellitus (Type 2)

3. Uncontrolled Hypertension on or with complication.

4. Known case of Ischemic heart Disease Cardiac Heart failure and any other vascular disorder.

5. Aggravation of complaints.

6. Uncontrolled obesity with BMI >40

7. Patients develops any serious adverse effect (A necessitating hospitalization)

8. Any addiction of Tobacco & Alcohol

9. Pregnant Lady or lactating mother

10. unwilling Patient will be excluded.Grouping of patient

Minimum 60 patients of age group 21-60 years will be divided into groups selected randomly for the clinical trial.

Group A -Patients of this group will be treated with herbal compound 2 vati (250mg each) for 3 months

Group B - Patients of this group will be treated with herbal compound 2 vati (250mg each) for 3 months after three days of virechan karma

Diet Plan and Exercise protocol will be common both in two groups.



Critaria of selection of cases

Patient will be enrolled for clinical trial in this study on the basis of clinical and biochemical lab findings as per follows.

Clinical Criteria

Subjective parameter

Essential criteria

1.Snigdhaangta(smoothness)

2.Udaroarshva vriddhi(abdominal obesity)

3.Daurgandhya(foul smell fron body)

Nonessential criteria

1.Hridyautkleda(heaviness in chest)

2.Praseka(salivation)

3.Kasa(cough0

4.Shwasa(breathlessness)

Patient having allessential criteria and 50%nonessential criteria must be present for selection of cases.

Objective Parameter

1. Abdominal Obesity

2. BMI above 25

3. High Triglycerides

4. Low HDL cholesterol

5. High Blood pressure or using to lower blood pressure.

6. High fasting blood glucose

7. Increased blood clotting tendency

8. Insulin resistance.

9. High VLDL and VLDL level

In the patients minimum 50% objective parameter must be present for selection of cases.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Last Update Posted: 2025-07-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Inclusion criteria 1.
• Age- 21- 60 years 2.
• Fasting glucose 100 mg/dl- 140mg/dl 3.
• Blood Pressure 130/90 mm Hg-150/110mmHg 4.
• HDL 40mg/ dl -50mg/dl 5.
• Waist circumferance 90cm-110cm in men 80cm-100cm in women 6.
• BMI 25-40 7.
• Triglyceride 150mg /dl-200mg/dl 8.
• Patient having all essential criteria and minimum 50%nonessential criteria must be present for selection of cases 9.
• In the patients minimum 50% objective parameter must be present for selection of cases.

Exclusion Criteria

Exclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6. High fasting blood glucose	before trial,0day,1th month,2 month, 3 month after trial.
Objective Parameter	before trial,0day,1th month,2 month, 3 month after trial.
3. High Triglycerides	before trial,0day,1th month,2 month, 3 month after trial.
4. Low HDL cholesterol	before trial,0day,1th month,2 month, 3 month after trial.
9. High VLDL and VLDL level	before trial,0day,1th month,2 month, 3 month after trial.
In the patients minimum 50% objective parameter must be present for selection of cases.	before trial,0day,1th month,2 month, 3 month after trial.
1. Abdominal Obesity	before trial,0day,1th month,2 month, 3 month after trial.
2. BMI above 25	before trial,0day,1th month,2 month, 3 month after trial.
5. High Blood pressure or using to lower blood pressure.	before trial,0day,1th month,2 month, 3 month after trial.
7. Increased blood clotting tendency	before trial,0day,1th month,2 month, 3 month after trial.
8. Insulin resistance.	before trial,0day,1th month,2 month, 3 month after trial.

Secondary Outcome Measures

Name	Time	Method
Subjective parameter	essential criteria

Trial Locations

Locations (1)

State Ayurvedic College and Hospital Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Shahnuma Ansari

Principal investigator

07991756506

ansarishahnumaansari@gmail.com