| CTRI Number |
CTRI/2025/04/084508 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Vidarikand Churna and marichadi Churna in the management of stanya kshaya w.s.r to hypogalatia . |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Vidarikand Churna and Marichadi Churna in the management of Stanya Kshaya w.s.r to Hypogalactia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Panwar |
| Designation |
Pg scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
7974857684 |
| Fax |
|
| Email |
nishapanwat786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChandraprabha Pinge |
| Designation |
MS (Ayu), Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9420248023 |
| Fax |
|
| Email |
drchandraprabha0611@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChandraprabha Pinge |
| Designation |
MS (Ayu), Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
| Address |
Department of Prasuti Tantra Evum Stri Roga, Third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam kolar road bhopal
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9420248023 |
| Fax |
|
| Email |
drchandraprabha0611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462042 India |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal MP 462042 |
| Address |
Department of Prasuti Tantra Evum Stri Roga third floor room number 1 Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya alam Kolar road Bhopal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nisha Panwar |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
Third floor, room number 1
Department of Prasuti Tantra Evum Stri Roga Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
7974857684
nishapanwat786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mansarovar Ayurvedic Medical College Hospital and Research Centre Institutional thics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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: Vidarikand Churna , Reference: Bhavaprakasa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: Vidarikand Churna will be given twice a day for 90 days. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Marichadi churna , Reference: Harita Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Godugdha ), Additional Information: Marichadi churna will be given twice a day for 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients of Stanya Kshaya in normal delivery/ C-Section.
2. Age group of patient is in between 18-40 years.
3. Patient from 5 day of delivery upto 6 month. |
|
| ExclusionCriteria |
| Details |
1. Patients having any pathological condition, Breast carcinoma, Sheehan syndrome, immuno-compromised disorders, history of having Breast surgeries.
2. Alcoholism, infection and systemic diseases.
3. Patients have taken treatment for milk suppressive e.g. Tab. Bromocriptine.
4. Baby with congenital anomalies, birth trauma, baby having any pathological condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Vidarikand churna and Marichadi Churna in the management of stanya kshaya w.s.r. to hypogalatia |
120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CBC, Serum Prolactin |
120 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/04/2025 |
| 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="1"
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
|
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Brief Summary
|
Ayurveda is a branch of Atharvaveda, the self-creating Brahma before creating man, first formulated this science of life consisting of one lakh Slokas and thousand Adhyay. The Ayurvedic classics describe eight well branches of Ayurveda, which is known as Astang Ayurveda, Kaumarbhritya is part of Astang Ayurveda Prasati Evam Stree Rog also describe under Kaumarbhrity
Stanya kehaya in Ayurveda-Stanya is the Upodhatu of Rasadhate, after digestion of food the Rasa is formed or it is formed by the action of Rasaagani over Rasadhatu and it is also named as Jeevanam Madhur Prasad Bhaga of this Rasa circulating through entire body by the action of Vyana vayu reaches breast and it is termed as Stanya
According to Ayurvedic texts the Apara is formed by the Aartava, which instead of going down-wards (which is it direction of flow) get collected upwards because of hamper in the flow of Aartov Vaha Strotas due to Garbha in Garbhavati Stri. Rest of Artava helps to give Stana Pusti
Causes of Stanyaksaya is Krodha. Shoaka Avatsalya Bhaya Langhana Aayasa ets
Breast milk is the ideal food for the infant, no other food required by the baby until 6 month after birth, a healthy mother will produce about 500-800 ml of milk a day to feed her infant, Inadequate milk production is may be due to infrequent sucking or due to endogenous suppression of prolactin Pain, anxiety and insecurity may be the hidden reasons. |