| CTRI Number |
CTRI/2016/03/006709 [Registered on: 04/03/2016] Trial Registered Prospectively |
| Last Modified On: |
12/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Randomized placebo clinical study and life style interventionon Mesha Shringyadi Gugglu in Medovridhhi |
|
Scientific Title of Study
|
A RAndomiZed Placebo controlled Clinical Study on Mesha Shringyadi Gugglu And life style intervntion in the management of Medo Vridhhi( Hypertryglyceridemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhabatosh Debbarma |
| Designation |
MD scholar |
| Affiliation |
IPGT and RA GAU JAmnagar |
| Address |
Oppo. Relience mart 4th floor Dept of Kayachikitsa
IPGT and RA GAU Jamnagar
Oppo. Relience mart4th floor Dept of Kayachikitsa
IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8469053283 |
| Fax |
02882676856 |
| Email |
drbhabatosh02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMandip Goyal Guide Bhabatosh Debbarmascholar |
| Designation |
MD scholar |
| Affiliation |
IPGT and RA GAU JAmnagar |
| Address |
Oppo. Relience mart 4th floor Dept of Kayachikitsa
IPGT and RA GAU Jamnagar
Oppo. Relience mart4th floor Dept of Kayachikitsa
IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427572306 |
| Fax |
02882676856 |
| Email |
mandipgoyal22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhabatosh Debbarma |
| Designation |
MD scholar |
| Affiliation |
IPGT and RA GAU JAmnagar |
| Address |
Oppo. Relience mart 4th floor Dept of Kayachikitsa
IPGT and RA GAU Jamnagar
Oppo. Relience mart4th floor Dept of Kayachikitsa
IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8469053283 |
| Fax |
02882676856 |
| Email |
drbhabatosh02@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA gujarat ayurveda university jamnagar |
|
|
Primary Sponsor
|
| Name |
IPGT and RA Gau Jamnagar |
| Address |
Oppo Relience mart Hospital Road Ipgt and ra Gujarat Ayurveda University jamnagar 361008 |
| 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 |
| Dr mandip Goyal |
IPGTand Ra GAU Jmanagar |
Oppo relience mart gujarat Ayurveda University JAmnagar
Jamnagar
GUJARAT |
9978403467
02882676856
kaurmandip22@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe,IPGT&RA,JAMNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with hypertryglyceridemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mesha Shringyadi Guggulu |
Form ofCapsule
Dose in 2cap each 500mg) TDS
Mode of administration Oral
Time of administration Before breakfast, lunch and dinner
Anupana Luke warm water
Duration of 8 weeks
|
| Comparator Agent |
Placebo drug Suji powder |
Placebo Group:
Drug:Sooji powder
Form: capsule
Dose: 2cap(each cap. 500mg) TDS
Mode of administration Oral
Time of administration Before breakfast, lunch and dinner
Anupana Luke warm water
Duration 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
S.cholesterol >200mg/dl or/and
S.Triglyceride >150mg/dl or/and
S.L.D.L >130mg/dl or /and
S.H.D.L <40mg/dl
|
|
| ExclusionCriteria |
| Details |
Age below 25 and above 60 years
Patients suffering from type 1 dm and uncotrolled dm
patients having uncontrolled hypertention
past history of MI unstabe angina
renal disese liver disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to show changes in lipid proofile mainly S triglyceride level |
to show changes in lipid proofile mainly S triglyceride level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • By providing better effect on hypertriglyceridemia,drug may also reduce the risk of insuline resistance diabetes, metabolic syndrome, pancreatitis & IHD. |
Cange in lipid profile |
|
|
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 |
|
Date of First Enrollment (India)
|
04/04/2016 |
| 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="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
published after complte of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A randomied placebo controlled clinical study was carried out to evaluate the role of cap. Meshashringyadi Guggulu and life style intervention in the management of Hypertriglyceridemia (Medo Vriddhi). Approval of IEC (Ref No: PGT/7-A/ETHICS/2015-16/1490) dated 25.08.2015. The study has also been registered in CTRI (CTRI/2016/03/006709) on 04 .03 2016. Clinically diagnosed 45 patients were registered after taking written consent and randomly divided into two groups. In trial group 20 patients completed the treatment and 3 patients drooped out. In placebo group also 20 patients completed treatment and 2 patients dropped out. In trial group and placebo group patients were given Meshashringyadi Guggulu capsule and Sooji powder capsule respectively, 2 cap. thrice daily before breakfast, lunch and dinner with luke warm water for duration of 8 weeks. On completion of 8 weeks treatment, the trial grp and placebo grp provided 33.21% and 24.91% decrease in S. tryglyceride. In trial group complete remission was obserbed in 35%, marked improvement was obserbed in 25%, moderate improvement was obserbed in 15% and 10% remained unchanged while in placebo group complete remission was obserbed in 25%, marked imrovement in 30%, moderate improvement in 10%, mild improvement in 45%, 15% remained unchanged and 5% patients deteriorated during the clinical study. |