| CTRI Number |
CTRI/2024/10/074731 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Shatavari for Lactating women |
|
Scientific Title of Study
|
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Shatavari on Post-Partum Lactation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SHT-1078-2024-03, Version 1; dt. 27th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Sr. Consultant |
| Affiliation |
Trupti Hospital |
| Address |
Trupti Hospital, Gynecologic Division, 2nd floor, Devldaya Sociey 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 |
Sr. Consultant |
| Affiliation |
Trupti Hospital |
| Address |
Trupti Hospital, Gynecologic Division, 2nd floor, Devldaya Sociey 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
Public Query
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Sr. Consultant |
| Affiliation |
Trupti Hospital |
| Address |
Trupti Hospital, Gynecologic Division, 2nd floor, Devldaya Sociey Rd. Phase 1,
Devidaya Nagar, Thane West, Thane,
Maharashtra 400606
Thane
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 |
Plot No-1057-F2, PBN Center,
Road No. 45, Jubilee Hills Hyderabad,
Telangana 500033 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, Gynecology Division, 2nd Floor, Devldaya 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 |
| Institute Ethics Committee D Y Patil medical college Nerul Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: STANYAVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Identical Placebo capsule | Capsule containing starch 300mg |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy women between 20-40 years of age
2.Women with uncomplicated full-term delivery (vaginal or LSCS).
3.Women who have accomplished antenatal breastfeeding promotion protocol immediately postpartum or within three days of delivery.
4.Women able to understand the study requirements and can fill the study log diary, and follow other procedures required by the study protocol.
5.Must have the ability and willingness to sign an informed consent and to comply with all study procedures
|
|
| ExclusionCriteria |
| Details |
1.Postpartum women with contraindications to breastfeeding, such as HIV, chemotherapeutic drugs, radioactive substances, and babies with galactosemia.
2.Postpartum women with unstable conditions (i.e., postpartum hemorrhage, sepsis).
3.Women with known allergies to Shatavari or oats, raisins, almonds, cocoa, and honey.
4.Women whose babies require phototherapy, women with insufficient glandular tissue or breast surgery and any structural abnormality of the breast.
5.Women with a history of infertility, hypothyroidism, women with twins, or higher-order births.
6.Any known clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological, or neurological illnesses or the presence of any current psychiatric disorders in women will be considered as exclusion criteria.
7.If any other investigational drug was used within three months before the entry in this study or those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean time noticeable from birth to evident breast fullness after delivery
Total volume (ml) of breast milk produced on the third postpartum day; Measurement by Breast pump (Manual/Automatic).
|
Day 3- 72 hours after delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective assessments on time to noticeable breast fullness after delivery using five-point Likert scale. |
Day 3- 72 hours after delivery |
| Subjective assessments of mother regarding the well-being and happiness of newborn, regarding the state of lactation using five-point Likert scale |
Day 3- 72 hours after delivery |
| Subjective assessments of investigator regarding the well-being of the mother, and regarding the well-being of the newborn using five-point Likert scale. |
Day 3- 72 hours after delivery |
| Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs). |
Day 3- 72 hours after delivery |
| A proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs). |
Day 3- 72 hours after delivery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
16/10/2024 |
| 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="2"
Days="25" |
|
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
|
· 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. · All subjects will be followed-up during the study period (first 72 hours after delivery). |