| CTRI Number |
CTRI/2022/02/040171 [Registered on: 10/02/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO STUDY THE THE EFFECT OF MUSTAKATUKA CHURNA IN RASIED LIPID LEVELS |
|
Scientific Title of Study
|
CONTROLLED STUDY OF MUSTAKATUKA CHURNA IN RASA RAKTAGAT MEDO DUSHTI W.S.R. TO DYSLIPIDEMIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Dandekar |
| Designation |
PG Scholar |
| Affiliation |
School of Ayurveda, Dr.D.Y.Patil deemed to be University |
| Address |
Kayachikitsa Department, School of Ayurveda, Dr.D.Y.Patil deemed to be University, Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9637998998 |
| Fax |
|
| Email |
dr.akankshadandekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Dandekar |
| Designation |
PG Scholar |
| Affiliation |
School of Ayurveda, Dr.D.Y.Patil deemed to be University |
| Address |
Kayachikitsa Department, School of Ayurveda, Dr.D.Y.Patil deemed to be University, Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9637998998 |
| Fax |
|
| Email |
dr.akankshadandekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Satpute |
| Designation |
Associate Professor |
| Affiliation |
School of Ayurveda, Dr.D.Y.Patil deemed to be University |
| Address |
Kayachikitsa Department, School of Ayurveda, Dr.D.Y.Patil deemed to be University, Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9169720245 |
| Fax |
|
| Email |
kalpana.satpute@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| School of Ayurveda, Dr.D.Y.Patil deemed to be University |
|
|
Primary Sponsor
|
| Name |
Dr Akanksha Dandekar |
| Address |
Kayachikitsa Department, School of Ayurveda, Dr.D.Y.Patil deemed to be University, Nerul,Navi Mumbai. |
| 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 Akanksha Dandekar |
Dr D.Y.Patil School of Ayurveda, |
Kayachikitsa Department, School of Ayurveda, Dr.D.Y.Patil deemed to be University, Nerul,Navi Mumbai.
Thane
MAHARASHTRA |
9637998998
dr.akankshadandekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E788||Other disorders of lipoprotein metabolism. Ayurveda Condition: rasa raktagat medo dushti , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: MustaKatuka churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Atorvastatin | Medicine name: Atorvastatin
reference : Tripathi K.D essential of medical pharmacology 7th JP brothers.
Route: Oral
dosage form: tablet
dose 10mg
frequency: HS
kaal: nisha kaal
duration : 45days
anupan : jaal |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed dyslipidemia patients
Lipid Panel:
SR. NO. LIPID PANEL BORDERLINE
1 Total Cholesterol 200 to 293 mg/dl
2 LDL-C 130 to 159 mg /dl
3 HDL-C 35 to 45 mg/dl
4 Triglycerides 150-199 mg/dl |
|
| ExclusionCriteria |
| Details |
Age: <30, >75yrs
Pregnant women & lactating mothers.
Patients having history of serious cardiac disorders like myocardial
infarction, cardiac failure, COPD.
Untreated thyroid disorder.
Patients having any major illness like uncontrolled diabetes mellitus.
Known case of Asthma, neurological disorders, anemia (Hb<10mg/dl).
Known case of Renal insufficiency, nephrotic syndrome.
Known case of severe Liver diseases.
Known case of HIV positive and HbsAg positive patients.
Immune compromised patients.
Any serious medical and psychological condition subjects will not be
included.
Blood Lipid profile according to NCEP -According to Adult Treatment
Panel
SR. NO. LIPID PANEL DESIRABLE HIGH RISK
1 Total Cholesterol < 200 mg /dl >240 mg/dl
2 LDL-C > 130mg/dl 160-189 mg/dl
3 HDL-C - Male
- Female
< 40 mg/dl
< 50 mg/dl
4 Triglycerides >150 mg/dl 200-499 mg/dl |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Controlled study of MustaKatuka churna in rasa raktagat medo dushti w.s.r. to Dyslipidemia |
0 to 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of mustakatuka churna in management of dyslipidemia
To study the effects of Atorvastatin
To compare the results of both groups |
0 to 45 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/02/2022 |
| 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="1"
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
|
The present study is the clinical experimental study for completion under D.Y.Patil deemed to be University Total duration of trials is 1 years
TITLE: Controlled study of Mustakatuka churna in rasa raktagat medo dushti w.s.r. yo dyslipidemia
STUDY GROUP: Sample size 30 will be treated with Mustakatuka churna and 30 will be treated with Atorvastatin
STUDY CENTRE: School of Ayurveda D.Y.Patil Deemed to be University Nerul, NaviMumbai.
PG SCHOLAR: Dr. Akanksha Dandekar
GUIDE: Dr. Kalpana Satpute. |