| CTRI Number |
CTRI/2025/01/079238 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of ashwagandha in pregnant women |
|
Scientific Title of Study
|
Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Pregnant Women: A Prospective, Randomized, Comparative 12-week Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARE-1195-2024-01, Version 1.0; dt. 30th Nov 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Principle investigator |
| Affiliation |
Trupti Hospital |
| Address |
Trupti hospital, Ground floor, Opd no.1,Devidaya Society Rd. Phase 1,
Devidaya Nagar, Thane West, Thane, Maharashtra 400606.
Thane
MAHARASHTRA
400606
India |
| Phone |
9757086159 |
| Fax |
|
| Email |
ashutosh.ajgaonkar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Principle investigator |
| Affiliation |
Trupti Hospital |
| Address |
Trupti hospital,Ground floor, Opd no 1, Devidaya Society Rd. Phase 1,
Devidaya Nagar, Thane West, Thane, Maharashtra 400606.
MAHARASHTRA
400606
India |
| Phone |
9757086159 |
| Fax |
|
| Email |
ashutosh.ajgaonkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Principle investigator |
| Affiliation |
Trupti Hospital |
| Address |
Trupti hospital,Ground floor, Opd no. 1, Devidaya Society Rd. Phase 1,
Devidaya Nagar, Thane West, Thane, Maharashtra 400606.
MAHARASHTRA
400606
India |
| Phone |
9757086159 |
| Fax |
|
| Email |
ashutosh.ajgaonkar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills
Hyderabad, Telangana 500033 India |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
5-9-225, Sanali Estate, Abids, Hydrabad-500001 Ph (91)40-23204385/86/87 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ashutosh Ajgaonkar |
Trupti Hospital |
Trupti hospital,
gynaecology division,
1st Floor, Devidaya
Sociey Rd. Phase 1,
Devidaya Nagar, Thane
West, Thane,
Maharashtra 400606
Thane
MAHARASHTRA |
9757086159
ashutosh.ajgaonkar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha Root Extract (300 mg) Capsule plus Standard Hematinics |
Capsule containing Ashwagandha Root Extract (300 mg) two times a day (total 600 mg/day) plus Standard Hematinics for 12 weeks |
| Comparator Agent |
Standard Hematinics |
Standard Hematinics (as per site protocol) for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women aged between 18 and 35 years.
2.Pregnant women 12 to 24 weeks (second trimester) of pregnancy with a normal pregnancy status, without significant comorbid conditions.
3.Willing and able to follow the study protocol, including attending regular follow-up visits.
4.Provide written informed consent after understanding the study’s risks, benefits, and protocol details. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemoglobin,RBC indices (red blood cell count (RBC), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red cell distribution width (RDW). |
Baseline, Week 4, Week 8, Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The clinical adverse events, either spontaneously reported by the patient, or noticed by the physician will be recorded during the therapy. |
Baseline, Week 4, Week 8, Week 12 |
| Laboratory adverse events based on hepatic function tests (serum bilirubin, serum proteins, transaminases, alkaline phosphatase) and renal function tests (serum creatinine, BUN). |
Baseline, Week 12 |
| Maternal stress assessed using the Perceived Stress Scale [PSS-10]. |
Baseline, Week 4, Week 8, Week 12 |
| Maternal sleep quality assessed using the Pittsburgh Sleep Quality Index [PSQI]. |
Baseline, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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 Yet Recruiting |
| 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
|
All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Blood sampling for safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 4 (week 12). Blood sampling for efficacy parameters will be done from visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) to visit 4 (week 12). All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, visit 3 (week 8) ± 4 days and visit 4 (week 12) ± 4 days. The Adverse events, either spontaneously reported by the patient, or noticed by the clinician, will be recorded during the study. |