| CTRI Number |
CTRI/2025/03/083240 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of an Ayurveda formulation in lactation insufficiency |
|
Scientific Title of Study
|
Effectiveness and safety of AYUSH SS granules (Coded Ayurveda Formulation) in the management of Lactation insufficiency: A prospective single arm multi centric trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarada Ota |
| Designation |
Asst Director(Ay) |
| Affiliation |
Central council For Research In Ayurvedic Sciences |
| Address |
Central Ayurveda Research Institute, Bhubaneswar.
Bharatpur,Bhubaneswar
Khordha
ORISSA
751009
India |
| Phone |
9810425662 |
| Fax |
|
| Email |
otasarada@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghna P P |
| Designation |
Research Officer (Ay ) |
| Affiliation |
Central council For Research In Ayurvedic Sciences |
| Address |
Central council for Research in Ayurvedic Sciences.
Jawaharlal nehru Bharatiya Chikitsa Evum Homeopathy Anusandhan Bhavan, 61-65 Institutional Area,Opp D Block Janakpuri
West
DELHI
110058
India |
| Phone |
09074126423 |
| Fax |
|
| Email |
drmeghnapp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagwan Sahai Sharma |
| Designation |
Research Officer (Ay ) |
| Affiliation |
Central council For Research In Ayurvedic Sciences |
| Address |
Central council for Research in Ayurvedic Sciences.
Jawaharlal nehru Bharatiya Chikitsa Evum Homeopathy Anusandhan Bhavan, 61-65 Institutional Area,Opp D Block Janakpuri
West
DELHI
110058
India |
| Phone |
9968485854 |
| Fax |
|
| Email |
bssccras@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS)
61-65, opp. D Block, Institutional Area, Janakpuri, New Delhi, India 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences.
Jawaharlal nehru Bharatiya Chikitsa Evum Homeopathy Anusandhan Bhavan, 61-65 Institutional Area,Opp D Block Janakpuri |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayashri Shrikant Deshmukh |
Chatrapathi Shahu maharaj Shikshan Sansthas Ayurved Mahavidyalaya, Kanchanwadi |
Chatrapathi Shahu maharaj Shikshan Sansthas Ayurved Mahavidyalaya, Kanchanwadi, Paithan Road Chatrapathi Sambhaji Nagar
Aurangabad
MAHARASHTRA |
9325580777
dr.jayashrisdeshmukh@gmail.com |
| Dr Vidya Narayan |
JSS Ayurveda Medical College and Hospital, Mysuru |
JSS Ayurveda Medical College and Hospital, Mysuru
41/E, Lalithadripura road, Alanahalli, Mysuru-570028
Mysore
KARNATAKA |
9980760076
vidya.dr@gmail.com |
| Dr Rashmi Sharma |
Post Graduate Institute of Ayurveda, Dr. S.R.R.A.U, Karwar. |
Post Graduate Institute of Ayurveda, Dr. S.R.R.A.U, Karwar, Nagour Road, Jodhpur 342001, Rajasthan
Jodhpur
RAJASTHAN |
9782371381
vd_rashmi11@yahoo.com |
| Dr Papiya Jana |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center |
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and research Centre,RPC layout, pipeline road, Vijayanagar 2nd stage, Bengaluru-560104
Bangalore
KARNATAKA |
9886716216
drpapiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional human ethics Committee, JSS Ayurveda College, mysuru |
Approved |
| Institutional ethics Committee, Chatrapathi Shahu maharaj Shikshan Sanstha Ayurved Mahavidyalaya, Kanchanwadi |
Approved |
| Institutional Ethics Committee, PGIA Jodhpur |
Approved |
| Institutional ethics Committee, SKAMCH& RC Bangalore |
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: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayush SS granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
i. Exclusively breast feeding mothers of age between 20-40 years with the complaint of insufficient lactation
ii. Primi or multipara with full term Delivery (greater than or equal to 37 weeks) and singleton baby from healthy pregnancy
iii. Mother of Baby with birth weight greater than or equal to 2 kg who has not attained actual birth weight by 10 days
OR
After 10 days of age weight gain less than 20gm per day from 11th day of birth to 3rd month of birth
iv. Urination of baby less than 6 times per day
v. Mother willing and able to give written consent |
|
| ExclusionCriteria |
| Details |
i. Mothers with active herpes breast/breast abscess/retracted nipple/severely cracked nipples,
ii. Mother is a known case of Hepatitis B, HIV, Tuberculosis, Malignancy or other Chronic medical conditions.
iii. Mothers with engorgement of the breast/fullness of breast.
iv. Mother is taking medicine like Pseudoephedrine, methergine, bromocriptine or any other galactogogues (Allopathic/Ayurvedic)
v. Mother is a known case of Diabetes mellitus .
vi. Mother of neonate with congenital malformations which may interfere in breast feeding or necessitating surgery in first six months of life.
vii. Mother of baby presenting with acute respiratory infection, pneumonia, urinary tract infection, infective diarrhoea, meningitis at the time of recruitment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of mothers exclusively breast feeding. Weight gain greater than twenty gram per day among these exclusively breast fed babies. |
Baseline and every four weeks up to the end of 12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Assessment of the safety of Ayush- SS Granules (Assessed through laboratory parameters LFT, KFT) during the study period |
Baseline and at the end of 12weeks |
| • Assessment of the tolerability of Ayush - SS Granules (Assessed through reported withdrawal of participants due to incidence of Treatment emergent adverse events (GIT-related AE specifically) during the study period |
Baseline and every four weeks up to the end of 12weeks |
| • Assessment of treatment adherence through participant self-reported compliance log and used medication containers/strips/sachets |
Baseline and every four weeks up to the end of 12weeks |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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)
|
02/04/2025 |
| 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="2"
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
|
The study is being conducted to assess the effectiveness of Ayush SS granules in exclusively breastfeeding mothers with lactation insufficiency. it is a prospective, multi-centric, single-arm study with a total sample size of 480. The primary outcome is the proportion of mothers exclusively breastfeeding and weight gain greater than 20g per day in these exclusively breastfed babies at the time points -baseline and at the end of every month up to the end of 3 months. |