| CTRI Number |
CTRI/2022/11/047597 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the use of Vidangadi yog in the management of high lipid levels that is Hyperlipidemia in Sthaulya patient. |
|
Scientific Title of Study
|
A Randomized Standard Controlled Clinical trial to assess the efficacy of Vidangadi yog in the management of Hyperlipidemia in Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradnya Sham Londhe |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurveda and Research Centre, Nigdi ,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Third floor, kayachikitsa department, Sector no.25,Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9763132595 |
| Fax |
|
| Email |
pradnyalondhe96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mahesh Joshi |
| Designation |
H.O.D. Of Kayachikitsa Departmentt |
| Affiliation |
PDEAs College Of Ayurveda and Research Centre, Nigdi ,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Third floor, kayachikitsa department, Sector no.25,Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Sham Londhe |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurveda and Research Centre, Nigdi ,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Third floor, kayachikitsa department, Sector no.25,Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9763132595 |
| Fax |
|
| Email |
pradnyalondhe96@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College Of Ayurveda and Research Centre, Sector no 25, Nigdi ,Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College Of Ayurveda and Research Centre, Sector no 25, Nigdi ,Pune |
| Address |
PDEAs College of Ayurveda and Research Centre, Sector no.25,Pradhikaran,Nigdi,Pune |
| 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 Pradnya Sham Londhe |
Ayurved Rugnalay and Sterling Multispeciality Hospital , Nigdi, Pune |
Vitthal Rukhmini Road,Sector no 27,Kayachikitsa O.P.D no.117 Ground Floor,Nigdi Pradhikaran, Pune
Pune
MAHARASHTRA |
9763132595
pradnyalondhe96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Yog, Reference: Ashtanga Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Group A will be treated with Vidangadi Yog containing Vidanga,Nagar,Yavkshar,lohabhasma,Yav,Amalaki | | 2 | Comparator Arm (Non Ayurveda) | | - | TAB. Rosuvastatin 10 mg | Group B will be treated with TAB. Rosuvastatin 10 mg orally once a day at night with water in the age group of 25 to 60 years which includes follow up on 15th,30th,45th,60th,75th and 90th day |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from symptoms of Sthaulya.
2.Patients who are having two or more following symptoms will be included for study 1.SHWASADHIKYA ,2.ATI KSHUDHA, 3.AAYAS AKSHAMTA,4.ATI TRUSHAN,5.BALAHINATA,6.NIDRADHIKYA
3.Age group 25 to 60 yrs irrespective of genders.
4.B.M.I 25 to 39.9 Kg/M2.
5. Patients having Sr. Cholesterol level more than normal (above 200m/dl)or Patients having Sr. Triglyceride level more than normal (above 150 mg/dl)or both |
|
| ExclusionCriteria |
| Details |
1.Known case of Renal impairment , IHD, TB, AIDS, CA, Cerebral disease and Hepatitis.
2. Positive and suspected Covid 19 cases.
3.Known cases of uncontrolled diabetes mellitus (Hba1c above 9%).
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 compare the effect of Vidangadi yog and Tab. Rosuvastatin in the management of Hyperlipidemia in Sthaulya over the time period of 3 months with each 15th day follow up. |
90 days with follow up on
15th,30th,45th,60th,75th,90th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study if any weight loss happened due to effect of Vidangadi Yog in 3 months.
2.To observe the adverse effect if any. |
90 days with follow up on
15th,30th,45th,60th,75th,90th day |
|
|
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)
|
28/11/2022 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Being overweight is common problem of todays era. It is also associated most of the times with lipid level changes due to unhealthy habits such as sedentary life style, eating junk food, lack of exercise, stress. People are generally considerd obese when BMI is above 25 kg/m2 and Hyperlipidemia is when Serum Cholesterol level is more than 200mg/dl and Serum Triglyceride level is more than 150 mg/dl. According to WHO overweight and obese are among leading causes of death globally. According to Ayurveda Sthaulya is mainly due to Meda and Kapha dushti. Therefore Kaphaghna ,Deepana, Lekahana, and Ushana, katu ingredients are used in treatment in Sthaulya. Due to all this properties management of Sthaulya may be possible and it may also help in growth of saar medadhatu and redused hyperlipidemia and leads to healthy individuals. The main objective of this research work is to provide consolidated report on uses of properties of Vidangadi Yog and Tab. Rosuvastatin in the management of Hyperlipidemia in Sthaulya. |