| CTRI Number |
CTRI/2020/05/025211 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
01/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Panchtikhta Panchprasritiki Vasti in Madhumeha ( Diabetes Mellitus Type 2) |
|
Scientific Title of Study
|
Clinical Evaluation of
effect of Panchtikta Panchprasritiki Vasti in Madhumeha ( Diabetes Mellitus Type 2) |
| Trial Acronym |
Basti in DM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prof Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul campus uau haridwar |
| Address |
27A,Gangotri street Vishnu Garden, haridwar
27A,Gangotri street Vishnu Garden, haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul campus uau haridwar |
| Address |
27A,Gangotri Street Vishnu Garden, haridwar
27A,Gangotri Street Vishnu Garden,haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prof Uttam Kumar Sharma |
| Designation |
Professor and HOD |
| Affiliation |
Gurukul campus uau haridwar |
| Address |
27A,Gangotri Street Vishnu Garden, haridwar
27A,Gangotri Street Vishnu Garden,haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411149479 |
| Fax |
|
| Email |
druksm@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul campus near pandit lekharam hostel, UAU Haridwar |
|
|
Primary Sponsor
|
| Name |
Gurukul campus |
| Address |
Gurukul Campus UAU Haridwar |
| Type of Sponsor |
Government 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 |
| swati verma |
Gurukul campus haridwar |
Panchkarma department, room no 24.
Hardwar
UTTARANCHAL |
7037203136
Swativerma0892@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical comittee |
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 |
panchtikta panchprastriki basti |
panchtikta panchprastriki basti in kala basti schdule in two coarse with gap period of 15 days after every coarse of kala basti. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed madhumeha (diabetes mellitus type 2)
patient with hyperglycemia taking irregular medication, no medication, or mild medication. |
|
| ExclusionCriteria |
| Details |
patient having diabetes mellitus type 1
patient of diabetes mellitus type 2 on insulin
patient with complication like renal failure, neuropathy, etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of therapy,objectively all sign and symptoms were given scoring depending upon their severity:
1- markedly improvement : 76-100% relief in sign and symptoms
2-moderate improvement: 51-75% relief in sign and symptoms
3-mild improvement:26-50% relef in sign and symptoms
4-no improvement: 0-25% relef in sign and symptoms. |
At 16th day, 32th day, 48th day,62th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
blood sugar fasting
blood sugar pp
hba1c
urine examination routine
urine examination microscopic
hb%
t.l.c, d.l.c,
lipid profile
lft
kft |
At 16th day,32th day,48th day,62th day |
|
|
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)
|
01/06/2020 |
| 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)
|
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)?
|
|
Brief Summary
|
Ayurveda, the most rational and scientific among the ancient system of medicine, has immense potential to tackle many medical problems. Charka samhita has described 20 types of prameha, out of which 4 are vataj prameha. Madhumega is one of the vatapradhan and asadhayay vyadhi. The clinic features of madhumeha resemble with an mutragat disease named as diabetes mellitus. It is a group of metabolic disorder characterized by a high blood sugar over a prolonged period of time. |