| CTRI Number |
CTRI/2020/04/024639 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
01/04/2020 |
| 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
|
Comparitive study on Virechana Karma and Basti Karma followed by Vidangadi Churna in the Management of lipid imbalance. |
|
Scientific Title of Study
|
A Clinical Comparative Study on Virechana Karma and Basti Karma followed by Vidangadi Churna in the Management of Medoroga w.s.r. to Dyslipidaemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santvana Sharma |
| Designation |
M.D. (Ay.) Scholar, Part-1st P.G. Department of Kayachikitsa |
| Affiliation |
National Institute of Ayurveda, Jaipur-302002 |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur-302002
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9467632334 |
| Fax |
|
| Email |
sharmasantvana@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kishor Joshi MD Ay PhD Ay |
| Designation |
Professor and HOD P.G. Department of Kayachikitsa |
| Affiliation |
National Institute of Ayurveda Jaipur302002 |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda
Jaipur 302002
P.G. Department of Kayachikitsa
National Institute of Ayurveda
Jaipur302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santvana Sharma |
| Designation |
M.D. (Ay.) Scholar, Part-1st P.G. Department of Kayachikitsa |
| Affiliation |
National Institute of Ayurveda, Jaipur-302002 |
| Address |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur-302002
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9467632334 |
| Fax |
|
| Email |
sharmasantvana@yahoo.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda,
Jaipur-302002
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Santvana Sharma |
NIA Hospital Jaipur |
P.G. Department of Kayachikitsa
National Institute of Ayurveda,
Jaipur-302002
Jaipur
RAJASTHAN |
9467632334
sharmasantvana@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kshar Basti-16 days
Virechan with Abhayadi Modak-15 days
Vidangadi churana 3 gm. twice a day for 30 days |
Group A-Virechana Karma-Total Duration-15 days Route of administration- Orally,
Dipana and Pachana-Trikatu Churna 2gm.Duration-3 days
Snehapana - Accha Ghrita Paana-30m.l.to 250 m.l according to agni of patient Duration-5 days
Abhyanga -Til tail,Pradhana Karma -Abhayadi Modaka 2-6 tab.duration-1 day
Sansarjan Karma-6 days
Group B-Kshara Basti -Duration -16 days as Kala, Route of administration-By Anal route
Anuvasana basti 100 m.l. Til taila
Niruha Basti
Makshika 30 m.l.
Saindhava 12 gm.
Haridra, Triphala, Musta, Daruharidra, Shyonaka Chhaal -280 ml
Tila Taila -70 m.l.
Yava Kshara 12gm.
Gomutra 100 m.l.
Vidangadi Churna-3gm.twice a day with luke warm water, duration-30 days in both groups ,Route of administration- Orally,
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
corticosteroids,antidepressants,anticholinergics, immunosuppressant, oestrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
c)Symptomatic patient with clinical evidence of Heart failure.
d)Patients with poorly controlled hypertension (systolic >180 and diastolic >100 mm ofHg)
e)Patients with evidence of malignancy.
f)Patients on oral contraceptives.
g)Alchohol and /or drug abusers.
h)Hyper |
|
| ExclusionCriteria |
| Details |
a)Unstable angina: Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or severe Arrhythmia in the last six months.
b)Patients on prolonged (>6weeks) medication with corticosteroids,antidepressants,anticholinergics, immunosuppressant, oestrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study.
c)Symptomatic patient with clinical evidence of Heart failure.
d)Patients with poorly controlled hypertension (systolic >180 and diastolic >100 mm ofHg)
e)Patients with evidence of malignancy.
f)Patients on oral contraceptives.
g)Alchohol and /or drug abusers.
h)Hypersensitivity to any of the trial drugs or their ingredients.
i)Patients who have completed participation in any other clinical trial drugs or theiringredients in one month period.
j)Patients who have received any cholesterol lowering medication (Modern Drug) within last two weeks.
k)Associated with any rectal pathology like haemorrhoids, fissure not fit for Virechanaand Basti Karma etc.
l)Pregnancy, Lactation and patients having Dyslipidaemia due to drugs e.g.Glucocorticoids, Diuretics etc.
m)Patients having Lipid Profile-Serum Cholesterol>400mg dl, Serum Triglycerides > 400mg/dl, LDL Cholesterol > 250 mg/dl,HDL Cholesterol < 20 mg/dl.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in lipid profile
Change in BMI and BMI Prime.
Change in anthropometric parameters
|
Changes in lipid profile - 45 days
Change in BMI and BMI Prime. -45 days
Change in anthropometric parameters -45 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Cardiac risk will be assessed by Framinghms 10 years cardiac risk score |
After completion of trial 45 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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
|
I.
Null hypothesis [ Virechana Karma followed by Vidangadi Churna and Basti Karma followed by Vidangadi Churna are equally effective in the management of Medoroga w.s.r. to Dyslipidaemia..
Alternative hypothesis [H1]:
-
There is a difference between
Virechana Karma
followed by Vidangadi Churna and Basti Karma followed by Vidangadi
Churna in management of Medoroga w.s.r.
to Dyslipidaemia.
|
|