| CTRI Number |
CTRI/2024/07/071285 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Exploring The Health Impact Of Finger Millet Laddoo(Ragi Modak)on Middle aged Woman |
|
Scientific Title of Study
|
Assessment Of Finger millet Laddoo (Ragi modak) As Nutritional Supplement In Middle Aged Women With Reference To Physical, Physiological And Biochemical Parameters. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrTanvi Parikh |
| Designation |
PG scholar |
| Affiliation |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P.) |
| Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7016742718 |
| Fax |
|
| Email |
tanviparikh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Bansal |
| Designation |
Professor |
| Affiliation |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P.) |
| Address |
Department of Swasthvritta and Yoga
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425017573 |
| Fax |
|
| Email |
bansalcharu73@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTanvi Parikh |
| Designation |
PG scholar |
| Affiliation |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P.) |
| Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College & Institute Bhopal
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7016742718 |
| Fax |
|
| Email |
tanviparikh1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrTanvi parikh |
| Address |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P.)pin code-462003 |
| 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 |
| DrTanvi Parikh |
Pt.Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute |
OPD No-8 Swasthvritta And Yoga Department Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal Science Hills, Nehru Nagar - Kolar Bypass Road,
Bhopal 462003 (M.P.) India
Bhopal
MADHYA PRADESH |
9427120429
tanviparikh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt.Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute Bhopal (M.P) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Woman having Hb% less than 12 gmdL and more than 8 gmdL and Serum calcium less than 8.5 mgdL. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: dietary advice, Ritucarya: no, Acara Rasayana:no, Other:Nutritional dietetics, Pathya/Apathya:yes, Pathya:Ragi Laddu made from Ragi flour, jaggery, Ghee, juice of cicus qudrangularis., will be given to middle aged women for 45 days., Apathya:Junk food, excessive spicy food, excessive consumption of tea and coffee. | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:placebo, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women belonging to lower and upper lower socio economic status.
resident of Bhopal for minimum 5 years
willful to join study
normoglycemic and free from systematic disease and bleeding disorder
women with BMI less than 18.5
women having hemoglobin less than 12gm /dl and more than 8gm/dl
women having serum calcium less than8.5 mg/dl |
|
| ExclusionCriteria |
| Details |
Woman those are on iron and calcium medication.
Woman suffering from other than nutritional anaemia such as thalassemia, Sickle cell anaemia, sidero blastic anaemia will be excluded.
Woman associated with Hookworm infection and round worm infection and any systemic and chronic diseases like Type 2 &Type 1 Diabetes Mellitus, Bleeding disorder, PCOD, CVD, Essential hypertension, cancer, Rheumatoid Arthritis etc. will be excluded.
Woman associated with any mental disease like depression, cognitive function impairment will be excluded.
Women those underwent on some major surgery like cholecystectomy, Hysterectomy and
those are known case of Hypothyroidism, Hyperthyroidism, and any other hormonal imbalance.
Pregnant and lactating mothers and women those are on contraceptive pills will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It would be expected that proposed Finger Millet Laddoo (Ragi Modak) as food
supplement would be highly beneficial formulation to manage nutritional deficiencies such as anaemia and calcium deficiencies of middle aged women. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluated changes in weight , BMI, in middle aged women |
45 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/08/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Millet are used in many diseases that have etiology of dietetic error of modern lifestyle. Ragi has been reported to have significant amount of iron and calcium and with this clinical study it has been proposed to identify nutritional benefit of ragi laddu on middle aged women with effect on various clinical and biochemical parameters. |