FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O925||Suppressed lactation. Ayurveda Condition: STANYAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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: -
2Comparator ArmDrugClassical(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: -
3Intervention ArmDrugClassical(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.

 
Close