| CTRI Number |
CTRI/2019/10/021829 [Registered on: 31/10/2019] Trial Registered Prospectively |
| Last Modified On: |
30/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical trial on the effect of vrikshamla in sthaulya(Obesity) w.s.r.to Hyperlipidaemia |
|
Scientific Title of Study
|
An open labeled clinical trial on the effect of vrikshamla in sthaulya(Obesity) w.s.r.to Hyperlipidaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrIshwarayyaSMathapati |
| Designation |
Professor |
| Affiliation |
AGM Jain Ayurvedic medical college,Varur,Hubbali |
| Address |
Station road,Ambedkar circle
Haveri
AGM Jain Ayurvedic medical college,Varur,Hubbali
Dharwad
KARNATAKA
581110
India |
| Phone |
9448326790 |
| Fax |
|
| Email |
dr.ishwar.mathapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ManuR |
| Designation |
Profeesor Dept. Of Kayachikitsa |
| Affiliation |
Parul institute of Ayurveda |
| Address |
Parul institute of ayurveda,Vadodara,Gujarat
Parul institute of ayurveda,Vadodara,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9481328930 |
| Fax |
|
| Email |
dr.Manurajgopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrIshwarayyaSMathapati |
| Designation |
Profeesor Dept. Of Kayachikitsa |
| Affiliation |
AGM Jain Ayurvedic medical college,Varur,Hubbali |
| Address |
Station road,Ambedkar circle
Haveri
AGM Jain Ayurvedic medical college,Varur,Hubbali
Dharwad
KARNATAKA
581110
India |
| Phone |
9448326790 |
| Fax |
|
| Email |
dr.ishwar.mathapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Dept. of Kyachikitsa AGM Jain ayurvedic medical college,Varur-Hubli |
|
|
Primary Sponsor
|
| Name |
Dr ishwarayya s mathapati |
| Address |
AGM Jain ayurvedic hospital college,Varur-Hubli |
| 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 Ishwarayya mathapati |
AGM |
OPD and IPD Dept. of Kayachikitsa AGM Jain ayurvedic hospital Varur,Hubbali
Dharwad
KARNATAKA |
9448326790
dr.ishawar.mathapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cap.Vrikshamla |
Cap.Vrikshamla 500mg 2cap BD before meals with Luke warm water for 60days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both Males & females will be selected
Patient will be selected from the age group 20-50 yrs
Lipid profile level
Serum ch. Above -200 mg/dl
Serum tri. above -165mg/dl
LDL above – 150mg/dl
HDL belove – 70mg/dl
Patient of sthaulya diagnosed according to classical features.
Patients with BMI above -30
|
|
| ExclusionCriteria |
| Details |
Patients below the age of 20 years and above the 50 years.
Patients undergoing other treatment for sthaulya (obesity).
Known cases of Diabetes mellitus (Madhumeha),Hyperthyroidism, Thyrotoxicosis, Nephrotic syndrome, Hypertension, Cardiac patients, Gouty arthritis, Infectious diseases, Endocrinal and CNS disorders.
Hepatic Disorders
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of Vrikshamla is effective in the mangament of sthaulya (obesity)and Santarpanajanya vikaras.
|
Evaluation of Vrikshamla is effective in the mangament of sthaulya (obesity)snd Santarpanajanya vikaras. Assessment is done after 60days of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of Vrikshamla is not effective in sthaulya (obesity)and Santarpanajanya vikaras
|
The extract (water based) of Vrikshamla fruits has Amla, Katu and Madhura Rasa. It also has Laghu and Ushna Guna with predominance of Vayu and Agni Mahabhuta. The Deepana, Pachana and Kapha-Medohara properties of Vrikshamla are also mentioned in Ayurvedic literature and assessment done after 60 days of treatment |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2019 |
| 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="3"
Months="2"
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)?
|
|
Brief Summary
|
this is open labelled clinical trial on the effect of Vrikshamla in sthaulya(Obesity) w.s.r to Hyperlipidaemia, So for the concept of hyperlidaemia is the excess accumulation of lipids in the body, leading various acute or chronic condition, Ayrveda classics have also referred that Prayaha snehat medaha pravarrdhayet. Implying the fact that excess sneha is responsible for excess productiob of meda and such excessively produced meda causing avarodha or avarana of other,Dhatu leading to medoroaga /sthaulya-laxana as well as upadrava, here we can link the vikrutiwhich is explained in ayurveda with present modern knowledge about lipids.
so many preparations have been mentioned in our texts for the treatment of medodhatu vridhi. But keeping in mind availability, compatibility, cost and preparation of drug Vrikshamla were preferred and selected for the study |