| CTRI Number |
CTRI/2024/11/076149 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the therapeutic potential of rasanjana in the form of vati in sthaulya(obesity) |
|
Scientific Title of Study
|
Clinical evaluation of Rasanjana vati in Sthaulya(obesity) |
| Trial Acronym |
CERVO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansi |
| Designation |
P.G.Scholar |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital Roorkee Haridwar |
| Address |
Opd No 3 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7015095720 |
| Fax |
|
| Email |
choudharymansi368@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Sharma |
| Designation |
Associate professor |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital Roorkee Haridwar |
| Address |
Opd No 3 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7060398172 |
| Fax |
|
| Email |
charu22jan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi |
| Designation |
P.G.Scholar |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital Roorkee Haridwar |
| Address |
Opd No 3 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
7015095720 |
| Fax |
|
| Email |
choudharymansi368@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANSI Opd NO 3 Department Of P.G. Kayachikitsa Quadra Institute Of Ayurveda And Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar (India) 247667 |
|
|
Primary Sponsor
|
| Name |
Mansi |
| Address |
Opd No 3 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar(India) 247667 |
| 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 |
| Mansi |
Quadra Institute Of Ayurveda And Hospital |
Opd No 3 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital NH 58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar(India)247667
Hardwar
UTTARANCHAL |
7015095720
choudharymansi368@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Quadra Institute Of Ayurveda |
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: RASANJANA IN FORM OF VATI, Reference: ASHTANGA HRIDAYA UTTARTANTRA ADHAYA 40 SHALOKA 49, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having sign and symptoms of sthaulya as explained in ayurvedic texts 2. Patients within the age range of 20 to 50 years 3. Patients of any gender 4. Patients having BMI range of 25 to 40 kilogram per metersquare (i.e., overweight, obesity class 1 and class 2) |
|
| ExclusionCriteria |
| Details |
1. Patients having age of less than 20 years or greater than 50 years 2. Patients having BMI less than 25 kilogram per metersquare and greater than 40 kilogram per metersquare 3. Patients with known history of genetic syndrome and having major systemic disorders such as pulmonary diseases, HTN and DM, hepatic diseases, renal diseases and other endocrine disorders 4. Patients with psychiatric disorders and any other mental disorders 5. Patients with past surgical intervention for obesity 6. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in subjective parameters:
1.Chalasphika Udara Stana
2.Alasya
3.Dourbalyata
4.Swedadikyata
5.Daurgandhyta
6.Kshudraswasa
7.Atinidra
8.Atipipasa
9.Kshudhaatimatram |
First follow up- after 15 days of first trial.
Second follow up- after 15 days of first follow up.
Third follow up- after 15 days of second follow up.
Fourth follow up- after 15 days of third follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in objective parameters:
1.Body weight
2.BMI
3. Waist-hip ratio
4.Skin fold thickness(mid triceps) |
Assessment will be done on 0 day & 60 day. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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="6"
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
|
THIS IS AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE EFFECT OF RASANJANA IN THE FORM OF VATI FOR THE MANAGEMENT OF STHAULYA (OBESITY). It will be a clinical study of 30 patients suffering from obesity. Patient will be selected randomly irrespective of their gender, race, religion, occupation. Patients with classical features of Sthaulya attending the OPD/IPD of Kayachikitsa Department of Quadra Institute Of Ayurveda and Hospital, Roorkee will be selected for this clinical study. The patients between the age group of 20 to 50 years of age will be selected. The assessment of the trial will be done on the basis of subjective and objective parameters. The period of study is 18 months and duration of study is 2 months. Data depending upon above subjective and objective criteria and other variables will be collected and analyzed statistically. |