| CTRI Number |
CTRI/2023/07/055684 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Herbomineral Formulation (GASY) Medicine in Treatment of Diabetes Mellitus |
|
Scientific Title of Study
|
A Randomized Controlled Comparative Clinical Trial to Evaluate the Efficacy of Herbomineral Formulation (GASY) in the Management of Diabetes Mellitus Type 2. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivang Patel |
| Designation |
Pg Scholar |
| Affiliation |
parul institute of ayurveda |
| Address |
Parul Ayurved Hospital,
Opd No-116 Kayachikitsa Opd,
Parul University,
P.O.Limda, Tal-Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
8160130295 |
| Fax |
|
| Email |
shivang.4patel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Munishwar |
| Designation |
Associate Professor |
| Affiliation |
parul institute of ayurveda |
| Address |
Parul Ayurved Hospital,
Opd No-116 Kayachikitsa Opd,
Parul University,
P.O.Limda, Tal-Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9130642840 |
| Fax |
|
| Email |
nisha.munishwar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Munishwar |
| Designation |
Associate Professor |
| Affiliation |
parul institute of ayurveda |
| Address |
Parul Ayurved Hospital,
Opd No-116 Kayachikitsa Opd,
Parul University,
P.O.Limda, Tal-Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9130642840 |
| Fax |
|
| Email |
nisha.munishwar@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Opd no 116, Kayachikitsa department
Parul Institute of Ayurved, Parul University,
P.O.Limda, Tal-Waghodia, Vadodara, Gujarat.
|
|
|
Primary Sponsor
|
| Name |
Dean And Principal Faculty Of Parul Institute Of Ayurved |
| Address |
OPD no 116
Kayachikitsa department
Parul Institute Of Ayurved, Parul University,
P.O.Limda, Tal-Waghodia, Vadodara, Gujarat.
|
| Type of Sponsor |
Other [Parul Institute of Ayurved] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nisha Munishwar |
Parul Ayurved Hospital |
OPD no 116
Kayachikitsa Department
Parul Institute Of Ayurved, Parul University,
P.O.Limda, Tal-Waghodia, Vadodara, Gujarat.
Vadodara
GUJARAT |
9130642840
nisha.munishwar@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee of Parul institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: GASY, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ongoing Antidiabetic Medicine | Various Oral Hypoglycemic Agents such as Name:
1) Metformin
2) Glimepiride
3) Metformin plus Glimepiride
4) Glipizide
etc |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 %
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION:
-
Diabetes
mellitus (DM) is one of the most common metabolic disorders worldwide. The global prevalence
of diabetes mellitus (DM) has shown an upward trend over the past few decades. Diabetes
mellitus (DM) is divided into type 1 diabetes also termed as insulin dependent
diabetes mellitus [IDDM] and type 2 diabetes mellitus. The number of diabetic
people is expected to rise to 366 million in 2030. The present study will be
undertaken to evaluate the antihyperglycemic activity of formulation which
contain extracts of Areca Catechu, Gymnema Sylvester, Shilajit and Yasad
Bhasma.
NEED FOR STUDY: -
Diabetes Mellitus type
2 (DM-2) is still not completely curable by the present
antidiabetic therapy. Insulin therapy is the satisfactory approach in Diabetes Mellitus type 2 (DM-2), even though it
has several drawbacks like insulin resistance, anorexia, brain atrophy, and
fatty liver in chronic treatment. The present study is aimed to evaluate the
synergism 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) in
management of Diabetes Mellitus type
2 (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 AND
METHODS: -
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
·
Drug
Intervention: -
·
*On-going treatment will be continuing.
|
|
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)
|
|
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 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
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.
|