| CTRI Number |
CTRI/2021/03/032156 [Registered on: 19/03/2021] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| 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
|
ketaki basti in diabetetes mellitus-2 |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the effect of Ketaki mula niruha basti and madhutailika basti in
madhumeha with special reference to diabetes mellitus-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 Akshatha M |
| Designation |
PG Scholar |
| Affiliation |
Government ayurveda medical college |
| Address |
Department of panchakarma,
Opd no. 6A,Government ayurveda medical college, Bengaluru-09
Bangalore
KARNATAKA
560009
India |
| Phone |
7892373925 |
| Fax |
|
| Email |
akshatham77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananta S desai |
| Designation |
Guide and HOD |
| Affiliation |
Government ayurveda medical college |
| Address |
Department of panchakarma,
OPD no-6A, Government ayurveda medical college, Bengaluru-09
Bangalore
KARNATAKA
560009
India |
| Phone |
9448185896 |
| Fax |
|
| Email |
anantdesai30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshatha M |
| Designation |
PG Scholar |
| Affiliation |
Government ayurveda medical college |
| Address |
Department of panchakarma,
OPD no-6A, Government ayurveda medical college,Bengaluru-09
Bangalore
KARNATAKA
560009
India |
| Phone |
7892373925 |
| Fax |
|
| Email |
akshatham77@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Akshatha M |
| Address |
department of panchakarma,
OPD no.6A
Government ayurveda medical college, Bengaluru-09 |
| Type of Sponsor |
Other [self] |
|
|
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 AKSHATHA M |
SRI JAYACHAMARAJENDRA INSTITUTE OF INDIAN MEDICINE HOSPITAL |
DEPARTMENT OF PANCHAKARMA OPD NO.6A GOVERNMENT AYURVEDA BENGALURU-09
Bangalore
KARNATAKA |
7892373925
akshatham77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, government ayurveda college Bengaluru 09 |
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: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Ketaki niruha basti |
1.ketaki niruha basti with murchita tila taila for anuvasana in yoga basti pattern.
Dose: Ketakimoola niruha basti- 562 ml
Anuvasana basti - 40ml
Route of administration-rectal route.
Duration-25days
|
| Comparator Agent |
Madhutailika basti |
Madhutailika basti is administered in yoga basti pattern.
Dose:Madhutailika basti- 628 ml
Anuvasana basti - 40ml
Route of administration:Rectal route
Duration-25days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Post prandial blood sugar (ppbs) level between 160-280 mg/dL.
HbA1C level between 6.5%-11%.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with type 2 diabetes mellitus who are insulin dependent.
2.Subjects who are diagnosed to have complications like diabetic foot, diabetic retinopathy
and other secondary complications.
3.Other complications like cardiac, hepatic and renal complications.
4.Pregnant and lactating woman. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Polyurea
Polyphagia
Polydipsia |
25 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting blood sugar |
25 Days |
| Post prandial blood sugar |
25 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prameha is a tridoshaja vyadhi,4
produced due to over indulgence in heavy, richly nutritious
food, day sleep, lack of cleanliness, exercises and other sedentary habits.5 Madhumeha is one
among the types of prameha.6
It is one among astamahagada.7,8 It is a anushangi vikara.9
Diabetes mellitus-2 can be equated with madhumeha as both have similar etiologies, symptoms
and complications.
Global prevalence of Diabetes mellitus is estimated to be around 374 million in
2017 and projected to increase to 587 million adults by 2045 equalling 8.4% of total population.
It is more prevalent in low and middle income countries.10 Its incidence is also increasing at an
alarming rate. There were 65 million prevalent cases of diabetes in India in 2016.11 It Has
become of utmost importance to find ways to combat this disease.
Ketaki is one among wide variety of the drugs which has been described in the
treatment of meha.12 It is easily available, cost effective. Traditionally the roots of ketaki
believed to have antidiabetic, antidiuretic, cardiotonic and aphrodisiac properties.13
Madhutailika basti can be administered to the person who desires to take niruha
basti.
14 It is one among the bastis told by samhita in the treatment of meha.15A study has been
conducted on the effect of madhutailika basti in management of madhumeha by Doddabasayya
S Swamy and it found statistically significant result, hence this study, “A controlled clinical
study to evaluate the effect of Ketakimoola niruha basti and Madhutailika basti in
madhumeha w.s.r.t Diabetes mellitus-2â€, aims to assess the madhumehahara karma of
Kethakimoola niruha basti and Madhutailika basti, and to find better treatment among these. HYPOTHESIS H0: There is no difference in the effect of Ketaki niruha basti and Madhutailika basti in
madhumeha. H1: There is difference between effect of Ketaki Moola niruha basti and Madhutailika basti in
madhumeha. |