| CTRI Number |
CTRI/2020/01/022662 [Registered on: 08/01/2020] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management Madhumeha (Diabetes mellitus type 2) |
|
Scientific Title of Study
|
An open label clinical trial to evaluate the efficacy of Sugralo capsule in Madhumeha (Diabetes mellitus type 2) |
| Trial Acronym |
SDM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT REGISTERED ELSEWHERE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor, Department of Panchakarma |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Panchakarma, National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Shekhar Tiwari |
| Designation |
Medical Advisor Multani Pharmaceuticals Ltd. |
| Affiliation |
Multani Pharmaceuticals Ltd. New Delhi |
| Address |
Pharmacy Section, Multani Pharmaceutical Ltd
New Delhi
DELHI
110020
India |
| Phone |
9654350714 |
| Fax |
|
| Email |
dr.hstiwari@multani.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Upadhyay |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kayachikitsa, National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9915613039 |
| Fax |
|
| Email |
dr.abhishek82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multani Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Ltd |
| Address |
Multani Pharmaceuticals Ltd, T-10 Okhla Phase II road Pocket W, Okhla Industrial area, New Delhi-110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gopesh Mangal |
National Institute of Ayurveda |
OPD NO. 2, National Institute of Ayurveda Hospital, Jorawar Singh Gate, Amer Road, jaipur
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Ayurveda IEC |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sugralo Capsule |
Ingredients: Sugralo capsule (500 mg each) contains Jamuna (Syzygium cumini) (Seed), Gurmara (Gymnema sylvestre) (Leaves), Methi dana (Trigonella foenum graecum) (Seed), Vijaysara (Pterocarpus marsupium) (Hard wood), Shudh Shilajeet; which are triturated with juice of Guduchi (Tinospora cordifolia) (Stem), Karela (Momordica charantia) (Fruit extract).
Dose: 2 capsules (500 mg each) orally twice daily 30 minutes before meal with lukewarm water for 90 days.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed for the first time or Diagnosed cases not taking any medicine for 3 last months.
2. Patients with cardinal symptoms of Madhumeha described in Ayurveda classics.
3. Patients having F.B.S. in the range of 126 – 200 mg/dl and/or P.P.B.S. between 180-300 mg/dl will be selected for the study.
4. Patients willing and able to provide signed ICF prior to study will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patient with type 1 Diabetes mellitus.
2. Patients with type 2 Diabetes mellitus who are on insulin or oral hypoglycemic drugs.
3. Patients with FBS ≥ 200 mg/dl and/or PPBS ≥ 300 mg/dl.
4. Patients of Gestational Diabetes and Juvenile Diabetes.
5. Patient having Type-II DM with any other serious systemic disease.
6. Patients with complications like cardiac disorder, diabetic foot, Nephropathy and other secondary complications.
7. Diabetes Mellitus produced due to other illnesses like Acromegaly, Cushing’s syndrome, pancreatic disorders etc.
8. Individuals not willing to provide written Informed Consent Form.
9. Individuals participating in any other clinical trial.
10. Pregnant or lactating females.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in FBS |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Subjective parameters, PPBS, HbA1c and Urine Sugar |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/01/2020 |
| 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)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an open labeled single armed, single
centric, prospective clinical study to evaluate the efficacy of Sugralo
capsules on 50 patients suffering from Madhumeha (diagnosed for the first time
or diagnosed cases not taking any medicines for last 3 months). The study will
be conducted in Department of Panchkarma, NIA, Jaipur, Rajasthan. Sugralo
capsules will be administered in a dose of 2 capsules (500 mg each) orally 30
minutes before meal with lukewarm water for 90 days. The efficacy of Sugralo
capsules in patients of Madhumeha (diagnosed for the first time or diagnosed
cases not taking any medicines for last 3 months) by assessing Subjective
parameters, Fasting and Post Prandial blood sugar level (FBS and PPBS) and
Urine Sugar on Day 0, 30, 60 and 90. HbA1C will be assessed on Day 0
and 90. A proforma shall be
prepared incorporating the grading criteria for above mentioned parameters. |