| CTRI Number |
CTRI/2019/07/020314 [Registered on: 22/07/2019] Trial Registered Prospectively |
| Last Modified On: |
19/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study on the management of type 2 Diabetes Mellitus with Nisha katakadi Niruha basti and Dhanvantaram ghritha Matrabasti followed by Saptachakra Kashaya as shamanoushadi with two parellel groups A and B respctively with which only patient is blinded. |
|
Scientific Title of Study
|
A Single blind Double Armed Clinical study in the management of type 2 Diabetes Mellitus with Nisha katakadi Niruha basti and Dhanvantaram ghritha Matrabasti along with Saptachakra Kashaya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Karlwad |
| Designation |
Assistant Professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
| Address |
Department of Kayachikitsa
OPD NO 21
Ayurveda Mahavidyalaya Hubli
Heggeri clony
Old Hubli
580024
amvhhubli@gmail.com
Department of Kayachikitsa
OPD NO 21
Ayurveda Mahavidyalaya Hubli
Heggeri clony
Old Hubli
580024
amvhhubli@gmail.com
Dharwad
KARNATAKA
580024
India |
| Phone |
9916259601 |
| Fax |
08362305122 |
| Email |
drmanjulakb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Karlwad |
| Designation |
Assistant Professor Department of Kayachikitsa |
| Affiliation |
AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
| Address |
Department of Kayachikitsa
OPD 21
Ayurveda Mahavidyalaya Hubli
Heggeri clony
Old Hubli
580024
amvhhubli@gmail.com
Department of Kayachikitsa
OPD 21
Ayurveda Mahavidyalaya Hubli
Heggeri clony
Old Hubli
580024
amvhhubli@gmail.com
Dharwad
KARNATAKA
580024
India |
| Phone |
9916259601 |
| Fax |
08362305122 |
| Email |
drmanjulakb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Karlwad |
| Designation |
Assistant Professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
| Address |
Department of Kayachikitsa
OPD 21
Ayurveda Mahavidyalaya Hubli
Heggeri clony
Old Hubli
580024
amvhhubli@gmail.com
Department of Kayachikitsa
OPD 21
Ayurveda Mahavidyalaya Hubli
Heggeri clony
Old Hubli
580024
amvhhubli@gmail.com
Dharwad
KARNATAKA
580024
India |
| Phone |
9916259601 |
| Fax |
08362305122 |
| Email |
drmanjulakb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences Advance research grant
560041 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences Bengaluru |
| Address |
Rajiv Gandhi University of Health Sciences Bangalore Jayanagar 4th T block 560041 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurveda Mahavidyalaya and Hospital |
Heggeri colony Old Hubli 580024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjula Karlwad |
AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
Department of Kayachikitsa
OPD 21
Heggeri Colony Extension
Old Hubli
580024
Dharwad
KARNATAKA |
9916259601
08362305122
drmanjulakb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Study group
GROUP A
NIRUHA BASTI
Duration of therapy 10 Days
SHAMANOUSHADI
SAPTACHAKRA KASHAYA
Dose 25ml
Duration of therapy 30 Days
GROUP B
MATRA BASTI
Duration of therapy 10 Days
SHAMANOUSHADI
SAPTACHAKRA KASHAYA
Duration of therapy 30 Days |
Study group
GROUP A
BASTI
Dose 500 ml and 100 ml
Dosage form Liquid
Route of Administration Rectal route
Time of Administration Twice a day empty stomach in the morning & evening
Duration of therapy 10 Days
SHAMANOUSHADI
SAPTACHAKRA KASHAYA
Dose 25ml
Dosage form Liquid
Route of Administration Oral route
Time of Administration Twice a day empty stomach in the morning and evening
Duration of therapy 30 Days
GROUP B
BASTI
Dose 45 TO 60 ml
Dosage form Liquid
Route of Administration Rectal route
Time of Administration Afternoon after food
Duration of therapy 10 Days
SHAMANOUSHADI
SAPTACHAKRA KASHAYA
Dose 25ml
Dosage form Liquid
Route of Administration Oral route
Time of Administration Twice a day empty stomach in the morning & evening
Duration of therapy 30 Days |
| Comparator Agent |
Study group GROUP A NIRUHA BASTI Duration of therapy 10 Days SHAMANOUSHADI SAPTACHAKRA KASHAYA Dose 25ml Duration of therapy 30 Days GROUP B MATRA BASTI Duration of therapy 10 Days SHAMANOUSHADI SAPTACHAKRA KASHAYA Duration of therapy 30 Days |
Study group GROUP A BASTI Dose 500 ml and 100 ml Dosage form Liquid Route of Administration Rectal route Time of Administration Twice a day empty stomach in the morning & evening Duration of therapy 10 Days SHAMANOUSHADI SAPTACHAKRA KASHAYA Dose 25ml Dosage form Liquid Route of Administration Oral route Time of Administration Twice a day empty stomach in the morning and evening Duration of therapy 30 Days GROUP B BASTI Dose 45 TO 60 ml Dosage form Liquid Route of Administration Rectal route Time of Administration Afternoon after food Duration of therapy 10 Days SHAMANOUSHADI SAPTACHAKRA KASHAYA Dose 25ml Dosage form Liquid Route of Administration Oral route Time of Administration Twice a day empty stomach in the morning & evening Duration of therapy 30 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 to 60 yrs
Patients diagnosed to be suffering from madhu meha having classical signs and Symptoms like
Prabhoota mootrata
kshuda adhikya
Pippasa adhikya
Dourbalya
Shareera bhara haani
Kara pada daha Kara pada suptata
Diagnosed cases of TypeII Diabetes Mellitus
Patients of either sex will be taken
Both newly diagnosed & treated patients of age group between 18 to 60 years
Patients of Diabetes Mellitus having Fasting Blood Sugar greater than equal to 126mg per dl
to less than equal to 180mg per dl, Post Prandial Blood Sugar greater than equal to 140mg per dl to less than equal to 280mg per dl and raised urine sugar values
Patients with other systemic disease which will not interfere with present treatment
HbAlc |
|
| ExclusionCriteria |
| Details |
Patient with other systemic diseases
FBS less than 126 mg per dl and more than 180 mg per dl
PPBS less than 140 mg per dl and more than 280 mg per dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in laboratory parameters after shodhana and shamana on 45th day |
45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in the laboratory parameters 10th day and 30th day after shodhana
|
End of 10th day and 30th day
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
03/02/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication will be done only after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A comparative clinical study to see the efficacy of Nisha katakadi Niruha Basti and Dhanvantaram ghritha matrabasti in the management of Diabetes mellitus along with Saptachakra kashaya
The 100 selected patients fulfilling the inclusion criteria will be selected for the study The initial assessment examination and investigation relevant for the study will be done and documented
Study Group
Group A Nisha katakadiNiruha basti is administered in kalabasti schedule
Group B Dhanvantaram ghritha Matra Basti for10days
Patients will be evaluated based on standard subjective objective and investigation parameters before the treatment after the treatment and after followup
At the end of the study the data collected will be analyzed and final report will be prepared The study will be prepared for publications or for presentation The inward, outward file financial expenditures relevant bills and all the related relevant documents will be submitted to the university |