| CTRI Number |
CTRI/2014/05/004613 [Registered on: 22/05/2014] Trial Registered Retrospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulations in the patients of Type II Diabetes Mellitus. |
|
Scientific Title of Study
|
Clinical Evaluation of Nisha Katakadi Kashaya and Yashada Bhasma in the Management of Type II Diabetes Mellitus(Madhumeha). |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S K Sharma |
| Designation |
Research Officer Scientist-4 (Principal Investigator) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Ayurveda Regional Research Institute Mandi.Room No-2,1st Floor
Gandhi Bhavan,Tehsil Sadar,District Mandi Himachal Pradesh
175001 India
Ayurveda Regional Research Institute Mandi.Room No-2,1stFloor
Gandhi Bhavan,Tehsil Sadar,District Mandi Himachal Pradesh
175001 India
Mandi
HIMACHAL PRADESH
175001
India |
| Phone |
01905222857 |
| Fax |
01905222857 |
| Email |
arri.mandi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (Nodal Officer) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences
(CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy
Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block,Janakpuri West DELHI
Central Council for Research in Ayurvedic Sciences
(CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy
Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block,Janakpuri West DELHI
West
DELHI
110058
India |
| Phone |
01128525831 |
| Fax |
01128520748 |
| Email |
duadrpradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Dua |
| Designation |
Research Officer (Nodal Officer) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences (CCRAS) |
| Address |
Central Council for Research in Ayurvedic Sciences
(CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy
Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block,Janakpuri West DELHI
Central Council for Research in Ayurvedic Sciences
(CCRAS),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy
Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block,Janakpuri West DELHI
DELHI
110058
India |
| Phone |
01128525831 |
| Fax |
01128520748 |
| Email |
duadrpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Achanta Lakshmipati Research Center for Ayurveda,Chennai |
| National Ayurveda Research Institute for Vector Borne Disease,Vijayawada |
| National Research Institute for Panchkarma, Cheruthuruthy |
| Ayurveda Regional Research Institute Mandi. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Central Council for Research in Ayurvedic Sciences (CCRAS),
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy
Anusandhan Bhawan, 61-65, Institutional Area, Opposite D Block,
Janakpuri, New Delhi-110058, INDIA |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S K Sharma |
Ayurveda Regional Research Institute, Mandi |
Ayurveda Regional
Research Institute
Mandi.Room No-2,1st
Floor Gandhi
Bhavan,Tehsil
Sadar,District Mandi
Himachal Pradesh
175001 India
Mandi
HIMACHAL PRADESH
Mandi
HIMACHAL PRADESH |
01905222857
01905222857
arri.mandi@gmail.com |
| Dr P Srinivas |
Dr.Achanta Lakshmipati Research Center for Ayurveda,Chennai. |
Dr.Achanta Lakshmipati
Research Center for
Ayurveda, 2nd
Floor,VHS Campus,
TTTI Post,Taramani,Ch
ennai-600113,Tamilana
du
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
044-22541536
044-22541537
drsrinivaspitta@yahoo.co.in |
| Dr V Subhose |
National Ayurveda Research Institute for Vector Borne Disease, Vijayawada |
National Ayurveda
Research Institute for
Vector Borne Disease,
New Rajeev Nagar,Pay
akapuram,Vijayawada-
520015,Andhra
Pradesh
Krishna
ANDHRA PRADESH
Krishna
ANDHRA PRADESH |
0866-2402535
0866-2402144
dr_vsubhose@yahoo.com |
| Dr V C Deep |
National Research Institute for Panchkarma, Cheruthuruthy |
National Research
Institute for Panchkarm
a,Cheruthuruthy, P.O.
Thrissur District,Kerala
State-679531
Thrissur
KERALA
Thrissur
KERALA |
09447673116
04884-262366
drvcdeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurveda Regional Research Institute,Mandi. |
Approved |
| Institutional Ethics Committee, Dr.Achanta Lakshmipati Research Center for Ayurveda,Chennai |
Approved |
| Institutional Ethics Committee, National Ayurveda Research Institute for Vector Borne Disease, Vijayawada |
Approved |
| Institutional Ethics Committee, National Research Institute for Panchkarma, Cheruthuruthy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type-II Diabetese Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NISHAKATAKADI
KASHAYA,YASHADA BHASMA |
Group-1: NISHAKATAKADI
KASHAYA Dose – 15ml twice
daily(to be diluted with 45ml of
Water); Dosage form –
Kashaya(Liquid),Route of
Administration – oral;Time of
Administration-Twice a day
before food;
Anupana-Lukewarm Water;
Packing form- Bottle containing
450 ml Kashaya; Duration of
therapy-84 Days Group-2:
YASHADA BHASMA
Dose-125mg (1 Capsule) thrice
daily; Dosage form-
Capsule;Route of
Administration-oral; Time of
Administration-Thrice a day
before food; Anupana-Luke
warm Water; Packing
form-Plastic jar containing 45
Capsules; Duration of
therapy-84 days. Group-3:both
NISHAKATAKADI KASHAYA &
YASHADA BHASMA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are diagnosed to be Type II Diabetics by either HbA1c >6.5%. or BS-F>126 mg% of BS-PP >200 mg% / Diabetics who are on lifestyle modification & /or on Tab.Metformin upto 2gm/ day.
2. Willing to participate in clinical trial. |
|
| ExclusionCriteria |
| Details |
1. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy,
diabetic retinopathy, etc.
2. Patients suffering from Type-I / brittle diabetes mellitus.
3. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
4. Patient with poorly controlled Hypertension (>140 / 90 mm Hg).
5. Patient with poorly controlled Gycemic status(HbA1c>8 %).
6. Symptomatic patient with clinical evidence of Heart failure.
7. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl),uncontrolled
Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
8. Pregnant / Lactating women.
9. Patient on steroids, oral contraceptive pills or estrogen replacement therapy.
10. Alcoholics and/or drug abusers.
11. Patients with evidence of malignancy.
12. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
13. H/o hypersensitivity to any of the trial drugs or their ingredients.
14. Patients who have completed participation in any other clinical trial during the past six (06) months.
15. Any other condition which the Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Blood Sugar Fasting(10-12 hours after dinner) |
Change in Blood Sugar Fasting(10-12 hours after dinner) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Symptoms -Diabetes Symptoms Questionnaire (DSQ) |
At Baseline-84th day and at the end of follow up
on 98th Day |
| Change in Glycosylated haemoglobin (HbA1c%) |
At Baseline and 84th day |
Change in Blood sugar Post -Prandial. (100-120
minutes after breakfast) |
At Baseline, 14th day-28th day-42nd day-56th
day-70th day-84th day and at the end of follow
up on 98th Day |
| Change in the SF-36-Health Survey Score |
At Baseline,at 84th day and at the end of follow
up on 98th Day |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
14/02/2013 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
To be published after the completion of the clinical trials in all the four centers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Central Council for
Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the
Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and
Homeopathy), Ministry of Health & Family Welfare, Government of India.
CCRAS is an apex body in India for the formulation, co-ordination,
development and promotion of research on scientific lines in the Ayurveda
system of medicine.
Aimed at generating
evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations,multicentre
clinical trials have been initiated in peripheral institutes of the
Council as an activity under the Intra Mural Clinical Research (IMR)
programme.
Nisha Katakadi Kashaya is a poly herbal preparation
containing: Nisha(Curcuma longa),Kataka(Strychnos potatorum),Dhatri(Emblica officinalis),Lodhra(Symplocus
racemosa),Paranti(Ixora coccinea),Bhadraka(Aerva lanata),Meharimula(Salacia reticulate),Ushira(Veitivera
zizanoides).
Yashada Bhasma is calcined preparation of Zinc.
The present study
entitled “Clinical Evaluation of Nisha Katakadi Kashaya and Yashada
Bhasma in the Management of Type II Diabetes Mellitus†is being undertaken
in four peripheral institutes of the CCRAS.
The cumulative evidence
generated as an activity under the IMR programme is expected to scientifically
substantiate the claims regarding clinical efficacy and safety of these
classical Ayurvedic formulations. |