| CTRI Number |
CTRI/2019/10/021761 [Registered on: 23/10/2019] Trial Registered Prospectively |
| Last Modified On: |
21/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparative effect of Bhumyamalaki and Curcuma powder in Diabetis. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Madhumehahara (Anti-Hyperglycaemic) Activity Of Bhumyamalaki ( Phyllanthus amarus Schum and Thonn.) And Haridra ( Curcuma longa Linn.)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHaritha Mathew P |
| Designation |
PG Scholar |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Department Of Dravyaguna
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Hassan
KARNATAKA
573201
India |
| Phone |
8547743164 |
| Fax |
|
| Email |
haritha7.hm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrakash L Hegde |
| Designation |
Professor and HOD |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Department Of Dravyaguna
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Hassan
KARNATAKA
573201
India |
| Phone |
9448227115 |
| Fax |
|
| Email |
drprakashlhegde@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
DrPrakash L Hegde |
| Designation |
Professor and HOD |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
Department Of Dravyaguna
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital
Hassan
KARNATAKA
573201
India |
| Phone |
9448227115 |
| Fax |
|
| Email |
drprakashlhegde@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri DharmasthalaManjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
College Phone: 08172256460
Email: college@sdmcahhassan.org
|
|
|
Primary Sponsor
|
| Name |
Sridharmasthala Manjunatheshwara college of Ayurveda and Hospital |
| Address |
Sri DharmasthalaManjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
College Phone: 08172256460
Email: college@sdmcahhassan.org
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Haritha Mathew P |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Sri DharmasthalaManjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA |
08172256460
haritha7.hm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India College Phone: 08172256460 Email: college@sdmcahhassan.org |
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 |
| Intervention |
Bhumyamalaki |
Oral administration of Bhumyamalaki Panchanga choorna 3 gm along with water will be given twice daily before food, for a duration of 60 days. |
| Comparator Agent |
Haridra |
Oral administration of Haridra Rhizhome a powder 3 gm along with water will be given twice daily before food, for a duration of 60 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Specific bio chemical investigations will be done on subjects with Post prandial blood sugar level between 160 to 280 mg/dL will be selected for study.
2.Subjects who have discontinued oral hypoglycemic drugs after washout period of 3 months
3.Subjects first time diagnosed .
|
|
| ExclusionCriteria |
| Details |
1. Subjects with Type 2 Diabetes mellitus who are insulin dependent.
2. Subjects with complications like Cardiac disorder, Diabetic foot, Nephropathy and other secondary complications
|
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Increased micturition, sweetness in mouth, burning sensation in soles and palms, dryness of oral mucosa, polyphagia, polydipsia, laziness, excessive sweating, bad smell, excessive sleep, Heaviness of body, debility |
First Day, 15 th Day. 30th Day, 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FBS,FUS,PPBS,PPUS |
First Day, 15th Day, 30th Day, 60th Day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/10/2019 |
| 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="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study aims to evaluate clinically the comparative Madhumehahara action of Bhumyamalaki Panchanga Choorna (Phyllanthus amarus Schum and Thonn.) and Haridra kanda Choorna ( Curcuma longa Linn.).The patient will be selected from out patient and in patient department of SDMCAH Hassan and will be studied in 2 groups.The study group will be given bhumyamalaki panchanga choorna and standard group will be given Haridra kanda choorna 3 gm twice daily before food.The data will be collected in case report form designed for the study.FBS, PPBS, FUS and PPUS will be checked on first,15th 30th and after 1 month follow up.The data collected will undergo required statistical tests.The changes with p value less than 0.05% will be considered as statistically significant. |