| CTRI Number |
CTRI/2018/02/011874 [Registered on: 13/02/2018] Trial Registered Prospectively |
| Last Modified On: |
13/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [yoga and diet regiment] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of the drug lekhaniya mahakashaya on patients of obesity(hyperlipidemia) |
|
Scientific Title of Study
|
upshyatmak study of lekhaniya mahakashya on sthaulya (hyperlipidemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Prof HOD of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73 |
| Address |
PG Department of Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73
Block D Room No 4 Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73
New Delhi
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Prof HOD of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73 |
| Address |
PG Department of Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73
Block D Room No 4 Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73
New Delhi
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drsurjeet kumar |
| Designation |
PG Scholer of Rog Nidan Evum Vikriti Vigyan |
| Affiliation |
Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73 |
| Address |
PG Department of Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73
Block A Room No 15 Ch Brahm prakash aurved charak sansthan khera dabar najafgarh 73
New Delhi
DELHI
110073
India |
| Phone |
9453915196 |
| Fax |
|
| Email |
surjeetkumar179@gmail.com |
|
|
Source of Monetary or Material Support
|
| ch brahm prakash ayurved charak sansthan khera dabar najafgarh 73 |
|
|
Primary Sponsor
|
| Name |
Ch brahm prakash ayurved charak sansthan khera dabar najafgargh |
| Address |
ch brahm prakash ayurved charak sansthan khera dabar najafgarh 73 |
| Type of Sponsor |
Other [state goverment ayurved 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 |
| Prof Dr Vidula Gujjarwar |
Ch brahm prakash ayurved charak sansthan khera dabar najafgarh 73 |
opd no. 20 of Rog Nidan Evum Vikriti vigyan and opd 22 of atayayik chikitsa
New Delhi
DELHI |
9990174348
shreemahalaxmi1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ch brahm prakash ayurved charak sansthan khera dabar najafgarh NCT New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient of sthaulya (Hyperlipidemia), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lekhaniya mahakashaya |
DOSE- 48 gm, kwath form twice daily,2 hr. before meal |
| Comparator Agent |
Pathya ahar vihar and yoga asan |
Pathya ahar vihar and yoga asan for 40 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The well diagnostic pt.of sthaulya (Hyperlipidemia)will be selected s.cholesterol->200mg/dl s. triglyceride- > 150mg/dl s.LDL- >110 S.VLDL-> 40mg/dl |
|
| ExclusionCriteria |
| Details |
pt. suffering with any systemic disease like cardiac and renal disease hypertention. pt suffering for endocrine disorder like diabetes thyroid dysfunction etc. pregnant females and lactating females |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduce symptoms of obesity and relief of symtoms
like atinidra,chala sphik,utsaha hani,kshudra shawas anga daurgandhya etc |
18 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.aetiopathogenesis of sthaulya will be assessed by adopting suitable subjective parameters.
2.Decrease elevated level of s.cholesterol s.triglyceride s. LDL S.VLDL Etc. |
18 month |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/03/2018 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Upshyatmak study of lekhaniya mahakashaya on sthauly |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Obesity is a prevalent nutritional disorder in which energy intake exceeds the energy output over a sufficiently long period of time and energy stores of the body remain too large, although the genetic component to obesity remains a possibility, it is unlikely to be great or to prevent weight loss being possible in most patient by reducing energy intake. environmental influences are believed to be more important in explaining the familial association in obesity.An inactive lifestyle is thought to play a role in the development of obesity. Drugs-Lekhaniya mahakashaya Dose- 48 gm BD with luke warm water Study type-Interventional Study time-18 Months Interventional time-40 Days Sample size-20 Patient in each group Group1- Lekhaniya mahakashaya kwath Group2- pathya ahar vihar and yoga asan and exerscise Assessment criteria- Subjective criteria- chal sphik, utsaha hani,ksudra swas,atinidra,swedadhikya,anga daurgandhya,anga gauravata,ati pipasa,ati ksuda Objective criteria- chest, abdomen, hip, mid thigh, mid arm, BMI range (kg/m2) |