| CTRI Number |
CTRI/2020/03/024258 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial to study the effect of Erand Kshar in Sthaulya (Obesity). |
|
Scientific Title of Study
|
Upasayatmaka study of Erand Kshar in Sthaulya W.S.R. to Lipid Profile. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sabhakant Pandey |
| Designation |
M D (Ayu) Scholar |
| Affiliation |
Shubhdeep Ayurved Medical College and Hospital Indore |
| Address |
Room No.F-24 Rog Nidan Evam Vikriti Vigyan Department,Shubhdeep Ayurved Medical College and Hospital Indore
Vill- Gujhawa POST- Naugawan Teh- Majhgawan Via Birsinghpur
Dist - Satna MADHYA PRADESH
Satna
MADHYA PRADESH
452020
India |
| Phone |
9713492286 |
| Fax |
|
| Email |
drsabhakantpandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A K Singh |
| Designation |
Principal Professor and HOD of Kaychikitsa |
| Affiliation |
Shubhdeep Ayurved Medical College and Hospital Indore |
| Address |
Room No.10 HOD of department of kayachikitsa, Shubhdeep Ayurved Medical College and Hospital Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
963001233 |
| Fax |
|
| Email |
doctoraksingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Masodker |
| Designation |
Assistant Professor |
| Affiliation |
Shubhdeep Ayurved Medical College and Hospital Indore |
| Address |
Room No.F-24 Rog Nidan Evam Vikriti Vigyan Department, Shubhdeep Ayurved Medical College and Hospital Indore
Shubhdeep Ayurved Medical College and Hospital Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9425657023 |
| Fax |
|
| Email |
masodker.pankaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| (Self) Dr.Sabhakant Panday Room NO. F-24 Rog Nidan Evam Vikriti Vigyan Department, Shubhdeep Ayurved Medical College And Hospital Indore. |
|
|
Primary Sponsor
|
| Name |
Dr Sabhakant Panday |
| Address |
Room no. F-24 Rog Nidan Evam Vikriti Vigyan Department, Subhdeep Ayurved Medical College , Indore |
| Type of Sponsor |
Other [ [ Self ]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pankaj masodker |
Shubhdeep ayurved medical college and hospital (P.G. Institute) |
Room No. F-24 Rog Nidan Evam Vikriti Vigyan Department.
Indore
MADHYA PRADESH |
9425657023
masodker.pankaj@gmail.com |
| Dr Sabhakant Pandey |
Shubhdeep ayurveda medical college and hospital |
Vill- Datoda khandwa road Indore ,
Indore
MADHYA PRADESH |
9713492286
drsabhakantpandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erand kshar 500 mg |
Erand kshar 500 mg + shuddha hingu 500 mg with 50 ml mand OD in morning,30days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients full filing criteria of sthaulya (Obesity).
2- Patients age between 20 to 50 years with irrespective gender.
3-Patients willing to consent for study.
4- sthaulya (obesity) based on BMI more then 30kg/m2. |
|
| ExclusionCriteria |
| Details |
1- Patients aged less then 20 years and more than 50 years.
2-Patients suffering from any other disorder with complication.
3-Pregnant & lactating women.
4-Patients not willing to follow treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Relief in dyspnoea on exertion(Ayasa Shwasa).
2)Relief in Sarva kriya asmarthata(Apathy).
3) Relief in krichh vyavaya(Difficulty in intercourse).
4) Relief in daurbalyata(Weakness).
5) Gatra Daurgandhata(Foul smell in human body).
6) Relief in Swedadhikya(Excessive Sweating).
7) Atikshudha (Excessive Hunger).
8) Atipipasa(Excessive Thirst), and as per modern Hyperlipidemia,Atherosclerosis,high blood pressure,ostioartheritis,impotency etc.
|
30 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
30/03/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The causes of Sthaulya according to Ayurveda are over eating, adhyashana, kaphavardhakaahar–vihara, avyayama, divaswapna, harsha (achintan) etc. Due to life style and lack of self awareness, peoples are affected with various disorders, one of them Sthaulya is more common in present era. India is currently most susceptible country to Sthaulya due to food habits and life style. In Ayurved, sthaulya has been described very early days in various samhitas,sangraha,granth etc. As Charak has described sthaulya among the eight most unwanted disease1 and santarpan janita roga2. Main responsible factor of Sthaulya are kled kapha, saman vayu and vyan vayu meda (fat/lipid) and medo-dhatvagni mandyata. A large number of drugs are indicated by Acharyas in each and every disease. The logical application of these spectra according to the different stage and conditions of the patient and disease is the prime key for the suitability of that drug in a given disease. In this study we are selected the eranda kshar for clinical trials to evaluate the efficacy of the erandakshar in Sthaulya. Eranda kshar prayog is the contribution of bhaishajya ratnawali special indication in medoroga (sthaulya)3 Sthoulya is a major risk factor for serious non-communicable disease as CVS, DM, HTN& various diseases. Several medicines are available for management of sthaulya but results are not promising.Ayurveda considers Sthaulyaroga as a disease due to over nutrition. Due to global effect of this disease which also includes huge number patients from our own country, so need of treatment is essential for society to achieve standardization of life with health.
|