| CTRI Number |
CTRI/2022/02/040033 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Trayushnadhyam churna in Sthoulya(Obesity). |
|
Scientific Title of Study
|
Efficacy of Trayushnadhyam churna in management of Sthoulya with special reference to Obesity. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sadhana Sampat Nalawade |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Institute. |
| Address |
Dr.D.Y.Patil College of Ayurved and Research Institute. Department of Kayachikitsa, Nerul, Navi Mumbai
Dr.D.Y.Patil College of Ayurved and Research Institute. Department of Kayachikitsa, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8898267251 |
| Fax |
|
| Email |
sadhanasn03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Sampat Nalawade |
| Designation |
PG Scholar |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Institute. |
| Address |
Dr.D.Y.Patil College of Ayurved and Research Institute. Department of Kayachikitsa, Nerul, Navi Mumbai
Dr.D.Y.Patil College of Ayurved and Research Institute. Department of Kayachikitsa, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8898267251 |
| Fax |
|
| Email |
sadhanasn03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dnyaneshwar M Padavi |
| Designation |
HOD & Professor |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Institute. |
| Address |
Dr.D.Y.Patil College of Ayurved and Research Institute. Department of Kayachikitsa, Nerul, Navi Mumbai
Dr.D.Y.Patil College of Ayurved and Research Institute. Department of Kayachikitsa, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9833158688 |
| Fax |
|
| Email |
dmpadavi@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD & IPD of Kayachikitsa Department Dr D.Y.Patil College of Ayurved and Research Institute |
|
|
Primary Sponsor
|
| Name |
Dr Sadhana Sampat Nalawade |
| Address |
Dr D.Y.Patil College of Ayurved and Research Institute Nerul Navi Mumbai |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sadhana Nalawade |
Dr D Y Patil College of Ayurved and Research centre |
Dr D Y Patil College of Ayurved and Research centre.
Department of Kayachikitsa
Nerul, Navi Mumbai
Thane
MAHARASHTRA |
8898267251
sadhanasn03@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: Trayushnadhyam Churna, Reference: Bharat bhaisajya Ratnavali- Vrudha yog tarang-104, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Gogruth), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having classical signs and symptoms of sthoulya(obesity). Those who are Obese and overweight e.g- BMI in between 25-40 |
|
| ExclusionCriteria |
| Details |
Subjects having any other major illness like heart disease, Diabetes, chronic kidney disease or any active malignancy.
Pregnant and lactating females.
Subjects having chronic infectious disease.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Trayushnadhyam churna in the management of sthoulya with special reference to obesity |
4-6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1- To study the etiopathogenesis of Sthoulya(Obesity) and correlate it with Ayurveda and Modern Science
2- To evaluate the efficacy and safety of Trayushnadhyam churna in the sthoulya
3- To study the action of trayushnadhyam churna in the management of sthoulya (Obesity). |
0-90 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2022 |
| 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="2"
Days="15" |
|
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)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION:- The present study is the clinical trial study for completion under Dr.D Y Patil Ayurved college and research institute. In which the estimated total duration of Trial is of 1 year.
TITLE:- Efficacy of Trayushnadhyam churna in the management of sthoulya wsr to Obesity.
STUDY GROUP:- Sample size- 60
STUDY CENTRE:- Dr.D Y Patil Ayurved College and Research Institute, Nerul, Navi Mumbai.
PG GUIDE:- Dr. Dnyaneshwar M Padavi
PG SCHOLAR:- Dr. Sadhana S Nalawade |