| CTRI Number |
CTRI/2024/05/066736 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study the effect of ayurvedic powders in mother milk insufficiency |
|
Scientific Title of Study
|
Open controlled clinical trial to evaluate the efficacy of Vidarikanda, Shatawari and Vidarikanda Shatawari Churna along with Godugdha in the Management of Stanyakshaya |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Ambekar Pradumn Sunil |
| Designation |
PhD scholor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya Kanchanwadi Aurangabad. |
| Address |
OPD no 19 Prasutitantra strirog OPD
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9403050636 |
| Fax |
|
| Email |
dr.pradumnambekar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vd Hawale Amol Anandrao |
| Designation |
Professor and Guide |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya Kanchanwadi Aurangabad. |
| Address |
OPD no 19 Prasutitantra strirog OPD
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9225306614 |
| Fax |
|
| Email |
amolhavale@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Vd Hawale Amol Anandrao |
| Designation |
Professor and Guide |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya Kanchanwadi Aurangabad. |
| Address |
OPD no 19 Prasutitantra strirog OPD
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9225306614 |
| Fax |
|
| Email |
amolhavale@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S. Ayurved Mahavidyalaya Kanchanwadi Aurangabad 431011 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Vd Ambekar Pradumn Sunil |
| Address |
C.S.M.S.S. Ayurved Mahavidyalaya Kanchanwadi Aurangabad 431011 Maharashtra |
| 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 |
| Vd Ambekar Pradumn Sunil |
C.S.M.S.S. Ayurved Rugnalaya |
OPD no 19 Prasutitantra Strirog OPD Aurangabad MAHARASHTRA |
9403050636
dr.pradumnambekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethicsl committee Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya & Rugnalaya Kanchanwadi Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O925||Suppressed lactation. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari Churna, Reference: Bhavprakash Nighantu - Purvakhanda Chapter 4 -Guduchyadi varga. Shlok no. 184, 185, 186, 187, 188., Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidarikanda Churna, Reference: Bhavprakash Nighantu - Purvakhanda Chapter 4 -Guduchyadi varga. Shlok no. 180, 181, 182, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari and Vidarikanda churna, Reference: Bhavprakash Nighantu Purvakhanda Chapter 4 -Guduchyadi varga. Shlok no. 180, 181, 182 Shlok no. 184, 185, 186, 187, 188, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: -Godugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Mothers who complainStanyakshaya symptoms after delivery
Mother having a 5th day neonateto12-month baby.
Breast milk quantity less than 300ml/day.
Patients who are willing to give consent for this study
|
|
| ExclusionCriteria |
| Details |
Known case ofbreast abscess, Mastitis, cracked nipples and breast cancer.
Babies on top feeding.
Breast milk production less than 50ml/day.
Infant with cleft palate.
Mother having a history of hormonal disorder.
Mother who is on oral contraceptive pills.
Patients suffering from Stanyakshaya due to any secondary cause like HIV, TB.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in insufficient lactation |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sufficient Weight gain in babies |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
14/05/2024 |
| 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="1" Months="6" 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
|
According World health Organization, Breast milk is like nectar for a childand it provides substantial advantages for both the mother and the child. Milk production is essential for optimum baby nutrition, as nutrition at this age has a direct impact not only on the newborn’s growthand health, but also on a healthy life. Exclusive breast feeding for first six months of life to child is also recommended on behalf of American Academy of Pediatrics. Stanyakshaya is a frequent issue, that most of mother’s face now a days. As a consequence of various unsanitary dietary and lifestyle habits, women are subjected to stress and strain. Since no alternative could be compared to mother milk, mother milk is an acceptable and complete food for the baby’s growth and development. Infant feeding motivates physical and emotional bonding between mother and child, resulting in a better parent-child relationship. Garbha’s Utpatti, Dharanaand Poshana, accompanied by Mother’s nourishment and trying to raise of the child. Stanykshaylakshane in mata: Stanyakshay, Stanyamlanata and Stanyasambhavalpataare the symptomsof Stanaykshay.
Sthanya kshaya is one of the vikruti of sthanya. In stanya kshaya there is kshaya due to anger, grief, absence of affection towards child, fear, fasting, exercise rukshanapanatiyogof shodhan therapy Ayurveda gives prime importance to the nutrition at every stage of life for preserving health of an individual. In first year of baby’s life, Proper nutrition is essential for the rapid growth and development of baby which obtains through mother milk. During this phase the baby is totally depending upon his mother for its nutrition. |