| CTRI Number |
CTRI/2024/07/069741 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Jamun seed powder with Nagarmotha tuber powder in management of obesity. |
|
Scientific Title of Study
|
Comparative evaluation of therapeutic efficacy of Jambu (Syzygium cumini
(L.) Skeels.) and Musta (Cyperus rotundus L. subsp.) in management of
Medoroga - An open randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Jagtap |
| Designation |
PG Scholar (Dravyaguna Vigyan) |
| Affiliation |
D Y Patil University, School of Ayurveda Nerul, Navi Mumbai |
| Address |
Department of Dravyaguna Vigyan, OPD No. 2, D Y Patil School of Ayurveda Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8395805840 |
| Fax |
|
| Email |
jyoti5070@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Charushila Giri |
| Designation |
Professor and HoD |
| Affiliation |
D Y Patil School of Ayurveda |
| Address |
Department of Dravyaguna Vigyan, OPD No. 2, D Y Patil School of Ayurveda, D Y Patil Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9892356496 |
| Fax |
|
| Email |
charushila.giri@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vd Charushila Giri |
| Designation |
Professor and HoD |
| Affiliation |
D Y Patil School of Ayurveda |
| Address |
Department of Dravyaguna Vigyan, OPD No. 2, D Y Patil School of Ayurveda, D Y PatilDeemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9892356496 |
| Fax |
|
| Email |
charushila.giri@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| DY Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706, India |
|
|
Primary Sponsor
|
| Name |
D Y Patil School of Ayurveda Deemed to be University Nerul Navi Mumbai |
| Address |
DY Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumbai-400706, India |
| 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 Charushila Giri |
DY Patil School of Ayurveda |
DY Patil School of Ayurveda, Dravyaguna Vigyana Department, OPD No.2, DY Patil Deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
9892356496
charushila.giri@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of DY Patil Deemed to be University, School of Ayurveda, Nerul |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jambu (Syzygium cumini (L.) Skeels, Reference: Sanhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta (Cyperus rotundus L. subsp., Reference: Sanhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having BMI more than 30. |
|
| ExclusionCriteria |
| Details |
Patients below 30 years, and above 50 years.
Patients having severe Cardiac anomalies.
Pregnant and lactating women.
Obesity produced due to certain secondary causes.
Drug induced Obesity.
Hereditary indisposition.
Patient suffering from any other grave disease also excluded.
Endocrinal origin Obesity excluded.
Diabetic patient excluded.
Patient doing exercise will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected difference of BMI of 0.5kg/m2 will be considered significant. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight reduction. |
180 days. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jyoti5070@gmail.com].
- For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In this era of modernization, Obesity is a curse to the human beings. In spite of advancement in treatment of Obesity, its prevalence is increasing significantly and is considered an emergency health problem all over the World. It is an epidemic in the world population and has been designated as a research priority by the leading global health organizations. It is a primary causal factor in many diseases, including type 2 Diabetes, Hypertension, Cardiovascular disease, Dyslipidaemia, Stroke, and Liver disease. The drug Jambu is selected in Medoroga for the present study as it is nontoxic, cost effective, can be administered orally, it has Sita Virya, Katu Vipaka, Kashaya, Tikta Rasas and Kapha ,Medohara property mentioned in Shushruta Samhita Adhyaya 38 Dravyasangrahaniya Adhyaya Shloka 48 of Nyagrodhadi Gana and many research activities experimentally proved the Hypolipidemic activity in modern science. Hence selected for clinical study with standard control drug Musta (RM Kalpana IJAPR-2014.2(3):355-363). The medication modalities in Ayurveda followed with inclusive utilization have an enormous impact in managing lifestyle disorders and that most of these disorders are preventable and many are even reversible. One key advantage of Ayurveda over Allopathy is that the herbs uses have minimal side effects, Allopathic medicines are synthesized in laboratories and have side effects ranging from mild to severe. Ayurveda provides a holistic healing approach that removes the problem from the root rather than just targeting symptoms. Ayurveda not only have potential to treat diseases but helpful to eradicate it completely which does not revert it and also help full to prevent one from causing diseases condition. |