| CTRI Number |
CTRI/2025/01/078930 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare effectiveness between sthaulyahar kashay ghana vati and tab rosuvastatin in the management of medovruddhi in sthaulya with special reference to hyperlipidemia |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To evaluate the efficacy between sthaulyahar kashay ghana vati and tab rosuvastatin in the management of medovruddhi in sthaulya with special reference to hyperlipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Mandar Pramod Garud |
| Designation |
PG Scholar |
| Affiliation |
PDEAS college of ayurveda and research centre , nigadi , pune |
| Address |
3 rd floor , kayachikitsa department,PDEAs College of Ayurveda and research centre, third floor kayachikitsa department , nigadi pradhikaran ,pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9405375962 |
| Fax |
|
| Email |
mandar.garud18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Vrinda Kurande |
| Designation |
professor kayachikitsa department |
| Affiliation |
PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune |
| Address |
3 rd floor , kayachikitsa department , PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7722030521 |
| Fax |
|
| Email |
vrinda.kurande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Mandar Pramod Garud |
| Designation |
PG Scholar |
| Affiliation |
PDEAS college of ayurveda and research centre , nigadi , pune |
| Address |
3 rd floor , kayachikitsa department , PDEAs College of Ayurveda and research centre, third floor kayachikitsa department , nigadi pradhikaran ,pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9405375962 |
| Fax |
|
| Email |
mandar.garud18@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3 rd floor , kayachikitsa department , PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune |
| Address |
PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune
411044 |
| Type of Sponsor |
Private medical 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 |
| DR MANDAR PRAMOD GARUD |
PDEAs college of ayurveda and research centre |
3rd floor , kayachikitsa department , PDEAs college of ayurveda and research centre , Nigadi Pradhikaran , Pune
Pune
MAHARASHTRA |
9405375962
mandar.garud18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E66||Overweight and obesity. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: sthaulyahar kashay ghana vati, Reference: sahasrayog, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: MADHU), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | rosuvastatin | rosuvastatin 10 mg at night for 12 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) BMI : 25.0 - 39.9 kg/m2
B) SR CHOLESTEROL : ABOVE 200 mg/dl TO 350 mg/dl
OR SR TRIGLYCERIDE : ABOVE 150 mg/dl TO 300
mg/dl OR SR LDL : ABOVE 150 mg/dl to 250 mg/dl
C)patient having 2 or more symptoms
1 Ati sthaulya (excess hunger)2 Ati trushna (excessthirst)3 Ati swed (excess sweating)4 Ati shwas (breathlessness)5 Ati nidrata (excess sleep)6 ays akshamata (fatigue)
above symptoms are from ashtang sangraha
|
|
| ExclusionCriteria |
| Details |
K/C/O
1 renal impairement, IHD, TB, AIDS, CA, cerebral diseases, hepatitis, hypothyroidism
2 uncontrolled DM (HbA1C above 9 %)
3 autoimmune diseases and taking steroid therapy
4 pregnant and lactating women |
|
|
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 get reduced BMI,
reduced trigyceride and cholesterol value,reduced symptoms of obesity as mentioned earlier
|
12 weeks follow up of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to observe adverse effect,if any |
12 weeks follow up of 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is one of the most challenging health issues in the present era.
It almost felt like an epidemic problem now days. Not only developed but
also the developing nations affected by this problem. Obesity is the
complex, multifactorial type of nutritional metabolic disease. It is a
medical condition in which body fat has accumulated to the extent that it
has a negative effect on health.
As we moved into rapid modernization, the lifestyle of an
individual has become sedentary. Today anything is available at the one
touch. Machine and smart gadgets’ have replaced manual labor. This
leads to the lack of exercise and there is increased popularity of fat
foods leading to impairment of metabolism. This leads to the disease
called ‘Sthaulya ’which is under Sampraptijanya vyadhi’ as Medorog.It
greatly increase risk of chronic diseases like disability, depression, type
2 DM, cardiovascular disease, Hyperlipidemia and many more serious
mental problems. There are many medicines available in allopathy for
management of Hyperlipidemia. Some famous medicines are like
Statins (Rosuvastatin, Atorvastatin etc.), Gemfibrozil, Ezetimibe,
Bezafibrates etc., but there are some side effects such as
myalgia,constipation,bloating. So, it is necessary to find out
some alternative medicine which will not harm towards body, which is
human friendly and also a cost effective.one of ayurveda literature saharasrayog adviced one formulation called sthaulyahar kashay ghana vati contains‘Vara’, ‘asan ’, ‘agnaya,
‘lohapatra’, ‘nisha ’ churna with anupan ‘Madhu’.Above all ingredients
have properties of ‘Kaphaghanta’, ‘Deepan’, ‘Lekhana’ and most of them
are ‘Ushna’ and ‘Katu’. So this combination is taken in order to cause
sampraptibhanga.Due to all this properties management of Sthaulya
may be possible and it may also help in growth of saar medadhatu and
leads to healthy individuals. |