| CTRI Number |
CTRI/2022/10/046110 [Registered on: 03/10/2022] Trial Registered Prospectively |
| Last Modified On: |
10/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare the effect of two medicines sthoulyahara choornam and varadi kashaya in the management of obesity |
|
Scientific Title of Study
|
A comparative clinical study on the effect of sthoulyahara choornam and varadi kashaya in the management of sthoulya w.s.r. 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 Jaykrishan Barman |
| Designation |
Postgraduate scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa,
Room no 17,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7076190013 |
| Fax |
|
| Email |
13201a003@sjsach.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvendu Rout |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa,
Room no 17,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444881980 |
| Fax |
|
| Email |
drsrout@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaykrishan Barman |
| Designation |
Postgraduate scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Department of Kayachikitsa,
Room no 17,
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
7076190013 |
| Fax |
|
| Email |
13201a003@sjsach.org.in |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, 600123 Department Of Kayachikitsa Opd |
|
|
Primary Sponsor
|
| Name |
Dr Jaykrishan Barman |
| Address |
Department of Kayachikitsa, room no 17, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Poonamallee, Chennai |
| 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 Jaykrishan Barman |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Department Of Kayachikitsa, Room No – 17, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpee, Poonamallee, Chennai, Thiruvallur, Tamil Nadu, 600123, India
Thiruvallur
TAMIL NADU |
7076190013
13201a003@sjsach.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sthoulyahara Choornam, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varadi Kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 20 – 70 years with signs & symptoms of sthoulya (obesity) will be selected.
2. Patients having BMI (body mass index) from 25 to less than equals to 35 will be included for the study.
3. Patients of any gender irrespective of socio-economic status.
4. Patient who are ready to sign the informed consent form will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients, who are suffering from pulmonary diseases, cardiac diseases, hypothyroidism, hypertension, pcod, and other major illness, will not be taken for the study.
2. Patients who are taking medications like - corticosteroid, hormonal therapy, psychiatric medication & protein powder, will not be taken in this study.
3. Patients having BMI greater than 35 kg/m2 will be also excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce weight, BMI, waist circumference, hip circumference, waist/hip ratio, skin fold thickness of patients |
On day 31 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/10/2022 |
| 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="6"
Days="0" |
|
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
|
Obesity is one among the major lifestyle disorders, which is increasing
rapidly and is gaining more attention at global level. It is seen both in
developing as well as in developed countries, irrespective of gender, age
groups and socioeconomic status. It is a multi-factoral metabolic disorder and
it’s primary cause is sedentary lifestyle, irregular food habits. In Ayurveda
it can be considered as Sthoulya and it has been mentioned in various samhitas
by our acharyas several years ago. Overweight and obesity are risk factors for
many health issues such as diabetes, hypertension, cva, joint problems etc. It
is difficult to prevent and treat lifestyle disorders with conventional system
of medicines. Ayurveda has a great potential to prevent and treat life style
disorders without any hindrance to body organs. In this study a humble attempt
is made to see the comparative effect of Sthoulyahara choornam and Varadi
kashaya in two groups in the management of Sthoulya (Obesity). To evaluate the
anti obesity effect of Sthoulyahara choornam in the management of Sthoulya (Obesity).
Sthoulyahara choornam in group – A, doses: 2 gm
of choornam (capsule form) will be taken thrice a day with luke warm water
after food. Time of administration: morning, noon and night, anupana: ushnodaka
and Varadi kashaya in group – B, doses: 50 ml of kashaya will be taken twice a
day before food. Time of administration: noon and night.
Null hypothesis – Sthoulyahara
choornam is not effective than Varadi
kashaya in the management of Sthoulya (Obesity) and alternative hypothesis – Sthoulyahara choornam
is better effective than Varadi kashaya
in the management of Sthoulya (Obesity). |