Use of Herbomineral Formulation (GASY) Medicine in Treatment of Diabetes Mellitus

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2023/07/055684
• Lead Sponsor: Dean And Principal Faculty Of Parul Institute Of Ayurved

Brief Summary

**INTRODUCTION:-**

Diabetesmellitus (DM) is one of the most common metabolic   disorders worldwide. The global prevalenceof diabetes mellitus (DM) has shown an upward trend over the past few decades. Diabetesmellitus (DM) is divided into type 1 diabetes also termed as insulin dependentdiabetes mellitus [IDDM] and type 2 diabetes mellitus. The number of diabeticpeople is expected to rise to 366 million in 2030. The present study will beundertaken to evaluate the antihyperglycemic activity of formulation whichcontain extracts of *Areca Catechu, Gymnema Sylvester, Shilajit and YasadBhasma.*

 **NEED FOR STUDY: -**

Diabetes Mellitus type2 (DM-2) is still not completely curable by the presentantidiabetic therapy. Insulin therapy is the satisfactory approach in Diabetes Mellitus type 2 (DM-2), even though ithas several drawbacks like insulin resistance, anorexia, brain atrophy, andfatty liver in chronic treatment. The present study is aimed to evaluate thesynergism effect of this combination in the management of the Diabetes Mellitus type 2 (DM-2).

 **AIM: -**

To evaluate the effect of Herbo mineral formulation (GASY) inmanagement of Diabetes Mellitus type2 (DM-2).

**OBJECTIVE: -**

- To evaluate the effect of Herbomineral formulation (GASY) on Blood parameters (FBS, PP2BS & HbA1C).

- To evaluate the effect of Herbomineral formulation (GASY) in type 2 DM on the basis of symptoms seen in patients.

- To evaluate the adverse effects, if any.

 **MATERIALS ANDMETHODS: -**

**Plant Material: -**

o  *Meshashringi* (Gymnema*sylvestre*) hydroalcoholic leaf extract.

o  *Poog- Phala (*Areca*catechu)* ethanol fruit extract.

 **Mineral Material:-**

o  *Shuddh shilajatu*

o  *Yashada bhasma*

·       **DrugIntervention: -**

·        \*On-going treatment will be continuing.

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| **GROUP 1(Adjuvant Group)**

**GROUP 2(Control Group)**

|**No. of Patients**

20

20

|**Mode of Administration**

Oral

Oral

|**Drug**

GASY+ Antidiabetic Drugs

Antidiabetic Drugs

|**Dose**

5g per day (Sachet)

-

|**Frequency and Time**

Twice Daily before food

(Morning and Evening)

-

|**Anupana**

Warm water

Warm water

|**Duration**

90 days

90 days

|**Follow up**

6 follow-ups each on every **15** days (+/- 5 days)

6 follow-ups each on every **15** days (+/- 5 days)

 

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| --- | --- |

|**Study type**

OPEN LABELLED CONTROLLED COMPARATIVE CLINICAL STUDY.

|**Study design**

Randomized, Open, Comparative Clinical Study.

|**Study centre**

OPD and IPD of Kayachikitsa Department, Parul Ayurved Hospital, Khemdas Ayurveda Hospital, Parul Sevashram Hospital**,** Camps and Other Referrals.

|**Sample size**

40

|**Duration of Treatment**

 90 days

 **INCLUSION CRITERIA: -**

1)Patient of either gender between the agegroup of 20-70 years of age (both years inclusive).

2) Known cases of Diabetes Mellitus.

3) Patients with FBS 125mg/dl to 300 mg/dl and PP2BS140 mg/dl to 400 mg/dl (both inclusive)

4) Patients with HbA1C levels between 7.0 –12.0 %

**EXCLUSION CRITERIA: -**

1) Patients having FBS more than 300mg/dl, PP2BSmore than 400mg/dl, HbA1C more than 12 %

2) Patients showing acute complications and chroniccomplications - neuropathy, nephropathy, retinopathy.

3) Lactating and Pregnant Women

 **WITHDRAWAL CRITERIA: -**

- During trial if there is any episode of serious adverse event which requires urgent intervention.

- Patients who want to withdraw from the clinical trial

- Those patients who do not appear for regular follow-up.

- During the course of trial, if patients FBS exceeds 300 mg/dl and PP2BS exceeds 400 mg/dl.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1. Patient of either gender between the age group of 20-70 years of age (both years inclusive).
• 2. Known cases of Diabetes Mellitus.
• 3. Patients with FBS 125mg/dl to 300 mg/dl and PP2BS 140 mg/dl to 400 mg/dl (both inclusive) 4) Patients with HbA1C levels between 7.0 – 12.0 %.

Exclusion Criteria

• 1. Patients having FBS more than 300mg/dl, PP2BS more than 400mg/dl, HbA1C more than 12 % 2) Patients showing acute complications and chronic complications.
• neuropathy, nephropathy, retinopathy. 3) Lactating and Pregnant Women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To Evaluate the Effect of Herbomineral Formulation GASY on Blood parameters FBS PP2BS & HbA1C	DAY 0 DAY 15 DAY 30 DAY 45 DAY 60 DAY 75 DAY 90

Secondary Outcome Measures

Name	Time	Method
To Evaluate the Effect of Herbomineral Formulation GASY in Type 2 DM on the Basis of Symptoms Seen in Patients	DAY 0 DAY 15 DAY 30 DAY 45 DAY 60 DAY 75 DAY 90
To Evaluate the Adverse Effects if any	DAY 0 DAY 15 DAY 30 DAY 45 DAY 60 DAY 75 DAY 90

Trial Locations

Locations (1)

Parul Ayurved Hospital; 🇮🇳 Vadodara, GUJARAT, India

Parul Ayurved Hospital

🇮🇳Vadodara, GUJARAT, India

Dr Nisha Munishwar

Principal investigator

9130642840

nisha.munishwar@paruluniversity.ac.in