| CTRI Number |
CTRI/2015/11/006390 [Registered on: 27/11/2015] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study to Evaluate Efficacy and Safety of Dabur Ratnaprash Sugar Free Diabetic patients |
|
Scientific Title of Study
|
A Two Arm, Randomized, Open Labeled, Prospective, Multi-Centre, Clinical Study to Evaluate Efficacy and Safety of Dabur Ratnaprash Sugar Free (DRDC/2015/003) in Controlled Type II Diabetic patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shishir Pandey |
| Designation |
Professor |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya |
| Address |
Ayurveda Research center,
Ayurved seva sangh,
Ganeshwadi, Panchavati
Nashik
MAHARASHTRA
422003
India |
| Phone |
0253-2543112 |
| Fax |
0253-2517170 |
| Email |
shishir.nsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs & Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
Dabur Research & Development Centre, Dabur India Ltd, Plot No.22, Site IV, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
01203378614 |
| Fax |
01204552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education & Research |
| Address |
Target Institute of Medical Education & Research,205 B Wing,Blue Diamond Society, Nayagoan Dahisar(West) Mumbai
Mumbai
MAHARASHTRA
400068
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research and Development Centre
Dabur India Limited
Plot No.22 Site IV
Sahibabad, Ghaziabad
|
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishir Pandey |
Ayurved Seva Singhs Ayurved Mahavidyalaya |
Ayurveda Research center,
Ayurved seva sangh,
Ganeshwadi, Panchavati,
Nashik, Maharashtra India 422003
Nashik
MAHARASHTRA |
9420830818
0253-2517170
shishir.nsk@gmail.com |
| Dr Neena Damle |
D Y Patil College of Ayurveda |
Department of Kayachikitsa
D Y Patil College of Ayurveda
Sector 7, Nerul, Navi Mumbai
Maharashtra, India 400706
Mumbai
MAHARASHTRA |
9769028549
02230965963
drneena.damle@gmail.com |
| Dr Narendra Kumar Mundhe |
KVTR College of Ayurved, Boradi |
Department of Kayachikitsa
KVTR College of Ayurved, Boradi,
Taluke Shirpur, District Dhule,
Maharashtra, India 425428
Dhule
MAHARASHTRA |
9850378206
drnbmunde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik |
Approved |
| D Y Patil University School of Ayurveda |
Approved |
| KVTR College of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Milk |
Glass of milk(100-200 ml) without sugar twice daily for 90 days. |
| Intervention |
Ratnaprash Sugarfree |
Dabur Ratnaprash Sugarfree is a poyherbal formulation contains permissible alternate sweeteners instead of conventional sugar. It has to be taken one teaspoon followed with glass of milk (100-200 ml) without sugar twice daily for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / poly drug oral anti-diabetic therapy.
2. Subjects having HbA1c value below 8% at screening.
3. Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening.
4. Subjects in the age group of 18 to 70 years, both inclusive.
5. Subjects of female gender or non-pregnant, non-lactating females, . A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form |
|
| ExclusionCriteria |
| Details |
1. Subjects on Insulin therapy.
2. Known cases of Severe/Chronic hepatic or renal disease.
3. Known subject of any active malignancy.
4. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
5. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
6. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
7. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
8. Subjects using any other investigational drug within 1 month prior to recruitment
9. Known hypersensitivity to any of the ingredients used in study drug
10. Pregnant and Lactating females.
11. Subjects currently participating in any other Clinical study
12. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assessment of changes in HbA1c % (Glycosylated Hemoglobin %) levels.
2. Assessment of quality of life (QOL) on WHO QOL Questionnaire |
90 Days (3 Months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess changes in fasting & pp plasma glucose,energy level, stamina, physical strength , stress level, symptoms of Diabetes, micro-albuminuria, dose of OHAs, Physician’s Global evaluation for overall change on CGI-I Scale,clinically significant abnormal laboratory parameters, Global assessment of overall safety of Dabur Ratnaprash Sugar free as per the physician & Subject
|
90 Days (3 Months) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is two Arm, Randomized, Open Labeled, Prospective, Multi-Centre, Clinical Study to Evaluate Efficacy and Safety of Dabur Ratnaprash Sugar Free (DRDC/2015/003) in Controlled Type II Diabetic patients. Study will be multicentric and type II diabetic subjects in age group of 18 to 70 years would be randomized to either of the two groups i.e Group A – one teaspoon of Dabur Ratnaprash Sugar free followed with a glass of milk without sugar twice daily for 90 days and Group B – a glass of milk without sugar twice daily for 90 days in 1:1 ratio.Both the groups will be advised to continue their regular diet/Exercise/Drug regimen as they were already taking. A glass of milk will be considered as 100-200 ml. Treatment period will be 90 days with total 8 visits including screening & randomization. Expected number of completers is planned to be 100 subjects. The study would include various assessment parameters including changes in glucose,energy,stamina, physical strength , stress, symptoms of Diabetes, micro-albuminuria, dose of OHAs, Physician’s Global evaluation for overall change on CGI-I Scale, clinically significant abnormal laboratory parameters,global assessment of overall safety of Dabur Ratnaprash Sugar free as per the physician & Subject |