| CTRI Number |
CTRI/2025/02/080315 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study of Effect of Kodo millet(Paspalum Scrobiculatum) As a Dietary Supplement in the management of sthaulya w.s.r. to Obesity. |
|
Scientific Title of Study
|
A Clinical Study of Effect of Kodo millet (Paspalum Scrobiculatum) As a Dietary Supplement in the management of sthaulya w.s.r.to Obesity |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita lade |
| Designation |
PG scholar |
| Affiliation |
Bhausaheb mulak ayurved mahavidyalaya nandanwan nagpur |
| Address |
Swastharakshan OPD of Bhausaheb mulak ayurved mahavidyalaya nandanvan nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7038499335 |
| Fax |
|
| Email |
ankitalade88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta s Talmale |
| Designation |
Associate professor |
| Affiliation |
Bhausaheb mulak ayurved mahavidyalaya nandanwan nagpur |
| Address |
Swastharakshan OPD of Bhausaheb mulak ayurved mahavidyalaya nandanwan nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9420733777 |
| Fax |
|
| Email |
dr.mamtasanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Ankita lade |
| Designation |
PG Scholar |
| Affiliation |
Bhausaheb mulak ayurved mahavidyalaya nandanvan nagpur |
| Address |
Bhausaheb mulak ayurved mahavidyalaya nandanvan nagpur maharastra
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7038299335 |
| Fax |
|
| Email |
ankitalade88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhausaheb mulak ayurved mahavidyalaya nandanvan nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Ankita lade |
| Address |
Swastharakshan OPD of bhausaheb mulak ayurved mahavidyalaya nandanwan nagpur |
| 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 Ankita lade |
Swastharakshan OPD |
Swastharakshan OPD of Bhausaheb mulak ayurved mahavidyalaya nandanwan nagpur
Nagpur
MAHARASHTRA |
7038499335
ankitalade88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Commitee of Bhausaheb mulak ayurved mahavidyalaya nandanvan nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOJA-VRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kodo millet , Reference: Charak samhita, Route: Oral, Dosage Form: Tandulodaka , Dose: 25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: with dal, sabji), Additional Information: kodo millet is not drug it is a food item that is use as a dietary supplement , in study we replace rice & use kodo millet as a rice recipe and ask patient to eat with dal and sabji before chapati, so it helps to manage diet of patient & reduce weight |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The patients suffering from signs and symptoms of sthaulya which is mentioned in classic ayurvedic texts i.e. karya- anutsaha, swedadhikya, daurgandhya, shram, kshudhadhikya, nidradhikya, & according to classification of obesity based on BMI criteria, having BMI 25.0 to 34.9 i.e. Overweight & class i obesity (obese), irrespective of sex, socio economic condition and religion etc. |
|
| ExclusionCriteria |
| Details |
1. Patients below age group of 20 year and above 40 year are excluded.
2. Patient with severe chronic disease.
3. Pregnant and lactating woman are not include
4. Patient who are suffering of known case of kidney disease.
5. Patient who are suffering of known case of hypothyroidism.
6. Patient who are suffering of sever and morbid obesity
7. Patient who exercise daily like gyming & swimming and other. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In the management of sthaulya (overweight, class I obesity) on reduction in weight assessed by BMI criteria, waist hip ratio, enthusiasm, debility, appetite and all symptoms given in subjective criteria. |
At the end of 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study effect of kodo millet (paspalum scrobiculatum) as a dietary supplement as it is laghu, ruksha, ushna, in guna, madhur, kasaya in rasatmak, vat vardhak, kaph pitta shamak, shoshan and grahi so the effect of kodo is assessed by reduction in weight, BMI criteria, & waist hip ratio, enthusiasm, debility, appetite and all symptoms given in subjective criteria. |
At the end of 90 days |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
03/01/2027 |
| 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="1"
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
|
To study effect of Kodo Millet (paspalum scrobiculatum) as a dietary supplement in the management of Sthaulya (Obesity) on reduction of weight assessed by BMI criteria, waist hip ratio, level of enthusiasm, debility, appetite, sleep, and all symptoms. This study will be carried out in Maharashtra state of India on Population. |