CTRI

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CTRI Number

CTRI/2025/03/081602 [Registered on: 04/03/2025] Trial Registered Prospectively

Last Modified On:

04/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Other

Public Title of Study

To see the Effect of Haridradi Granules in Increasing Breast Milk Supply in Mothers with Low Milk Production

Scientific Title of Study

EFFICACY OF HARIDRADI GRANULES IN THE MANAGEMENT OF STANYAKSHAYA: AN EXPLORATORY STUDY

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 Rukhsar
Designation	PG Scholar
Affiliation	All India Institute of Ayurveda
Address	Department of Stri Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi South DELHI 110076 India
Phone	9873081207
Fax
Email	rukhsarbams@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Meeta Jhala
Designation	Assistant Professor
Affiliation	All India Institute of Ayurveda
Address	Department of Stri Evam Prasuti Tantra Room no 411 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi South DELHI 110076 India
Phone	8107415431
Fax
Email	meetajiten6978@gmail.com

Details of Contact Person
Public Query

Name	Dr Meeta Jhala
Designation	Assistant Professor
Affiliation	All India Institute of Ayurveda
Address	Department of Stri Evam Prasuti Tantra Room no 411 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi South DELHI 110076 India
Phone	8107415431
Fax
Email	meetajiten6978@gmail.com

Source of Monetary or Material Support

All India Institute of Ayurveda Gautampuri New Delhi 110076

Primary Sponsor

Name	All India Institute of Ayurveda
Address	Mathura road Gautampuri Sarita Vihar Delhi 110076
Type of Sponsor	Government medical college

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
Dr Meeta Jhala	All India Institute of Ayurveda	Department of Stri Evam Prasuti Tantra Room no 411 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi South DELHI	08107415431 meetajiten6978@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Division of Translational Research & Biostatistics, Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:O924\|\|Hypogalactia. Ayurveda Condition: STANYAKSHAYAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Haridradi Granules, Reference: Tripathi Indradev Chakradatta. Chapter 63, Stree Rogachikitsa Prakranam, Shloka 46. 1st ed. Varanasi: Chaukhambha Sanskrit Bhawan, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	Age group between 20 to 35 years irrespective to religion, socio-economic status and food habits Patients either of Primigravida or Multigravida will be selected. Patients after delivery from 5th day to 6 months. Patients with previous history of lactation deficiency. Breast feeding frequency less than 4-5 times/day. Patient having baby of less than 6 month of age, partially or totally on top feed. Patient’s delivery should be at full term.

ExclusionCriteria

Details

Patient with congenital anomalies of breast (absence of nipple or the breast tissue).
Patient with breast atrophy, mastitis, breast abscess.
Patient with known case of immune compromised disease like AIDS, Cancer.
Patients with reactive viral markers.
Patient with known case of systemic disease like Diabetes mellitus.
Patient’s baby with congenital anomalies (cleft lip, cleft palate), birth trauma, premature birth.
Patient who is taking anti prolactin drug (bromocriptine, cabergoline) which suppress lactation.
Patient who is taking anti emetic drug (metoclopramide, domperidone) or antipsychotic drug (sulpiride) which increase lactation.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To find out the efficacy of Haridradi Granules in the management of Stanyakshaya.	2 months

Secondary Outcome

Outcome	TimePoints
To find out the effective weight gain in infants by improving quantity of breast milk.	2 months

Target Sample Size

Total Sample Size="47"
Sample Size from India="47"
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)

15/03/2025

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

Stanya is Jeevana Amsha as it is the chief source of nutrition and diet for new born baby .. Acharya Charaka has quoted that the new born should be put to breast from the very first day of birth. Stanya, as it is formed by Prasada of Ahara Rasa it contains best of all nutrients needed for the child.Stanyakshaya is one of the Vikruti of Stanya. In Stanyakshaya there is Kshaya due to Dhatukshaya and Dushti. Ayurveda Acharyas consider Stanyakshya to be a serious issue, and they have thoroughly described the condition, including the causative factors and management. Main causes are Langhana, Rukshannapana Sevana, Karshana (emaciation), Atyapatarpan (excessive fasting), Shodhana Atiyoga, Krodha, Bhaya, Shoka, Kama and Avatsalyatwa, etc.

OBJECTIVES

PRIMARY OBJECTIVE -

To find out the efficacy of Haridradi Granules in the management of Stanyakshaya.

SECONDARY OBJECTIVE –

To find out the effective weight gain in infants by improving quantity of breast milk.

METHODOLOGY

Study type	Exploratory
Primary Purpose	Efficacy
Masking	Open labelled
Timing	Prospective
Sample size	47
Primary Outcome	Changes in milk production rate from baseline to endline (60^th day)
Secondary Outcome	Changes in PIM (Perceived insufficient milk) score.

PARAMETER FOR ASSESSMENT OF STUDY OUTCOME –

During the trial and follow up study the patients will be assessed on the basis of parameters

SUBJECTIVE PARAMETERS :

The parental PIM score will be evaluate using the validated McCarter-Spaulding and Kearner Perceived Insufficient Milk Questionnaire.

OBJECTIVE PARAMETERS:

1. The Human milk production rate will be calculated at baseline and at endline using validated milk expression protocol.[i]

2. Weight of the baby will be calculated at baseline, during treatment and at 60^th day.

[i] Roznowski DM, Wagner EA, Riddle SW, Nommsen-Rivers LA. Validity of a 3-hour breast milk expression protocol in estimating current maternal milk production capacity and infant breast milk intake in exclusively breastfeeding dyads. Breastfeed Med. 2020;15:630-638. doi: 10.1089/bfm.2019.0182