| CTRI Number |
CTRI/2021/06/034353 [Registered on: 23/06/2021] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Effect Of Shatavari Churna And Musali Churna (Powder)In Lactation insuficency. |
|
Scientific Title of Study
|
Open Label Double Arm Comparative Clinical Study To Evaluate The Efficacy Of Shatavari Churna And Musali Churna In Stanya Kshaya. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidyavati Ranganata |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and research centre |
| Address |
Department of PG studies in Prasuti Tantra Evum Stree Roga
SKAMCH and RC
Pipeline road RPC layout Vijayanagara Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
7406331416 |
| Fax |
|
| Email |
rchavanvidyavati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Papiya Jana |
| Designation |
PROFESSOR |
| Affiliation |
SRI KALABYRAVESWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
Department of PG studies in Prasuti Tantra Evum Stree Roga
SKAMCH and RC
PIPELINE ROAD R P C LAYOUT VIJAYANAGAR BANGALORE 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9886716216 |
| Fax |
|
| Email |
drpapiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Papiya Jana |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and research centre |
| Address |
Department of PG studies in Prasuti Tantra Evum Stree Roga
SKAMCH and RC
Pipeline Road RPC Layout Vijayanagara Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9886716216 |
| Fax |
|
| Email |
drpapiya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vidyavati Ranganata |
| Address |
Sri Kalabyraveshwara Swmay Ayurvedic College Hospital And Research Centre |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran M Goud |
SKAMCH AND RC |
Department of PG studies in Prasuti Tantra Evum Stree Roga Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O924||Hypogalactia. Ayurveda Condition: SUTIKAROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Musali Churna |
Musali Churna Was Given Orally 3gm Twice Daily For 1 Month |
| Intervention |
Shatavari Churna |
Shatavari Churna Was Given Orally 3gm Twice Daily For 1 Month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Subjects from 5th day of delivery.
Subjects diagnosed as having Stanya Kshaya.
Primigravida and multigravida with age group of 18-35 years.
|
|
| ExclusionCriteria |
| Details |
Pathologies of breast like,
Breast engorgement,
Cracked or sore nipples,
Mastitis,
Flat or inverted nipples.
History of Breast abscess, trauma and surgery.
History of HIV, infections and other systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shatavari Churna Is More Effective Compared To Musali Churna In Stanya Kshaya. |
60 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shatavari Churna Is More Effective Conpared To Musali Churna In Stanya Alpata,Stanya Pramana And Weight Gain Of The Baby |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
28/06/2021 |
| 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="5"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to Ayurveda, Stanya is the upadhatu of Rasadhatu.3 According to Acharya Kashyapa during pregnancy, the food ingested gets transformed into Rasa and Rakta Dhatu where some of these nourishes the body parts of fetus, some is for production of breast milk and some parts for the digestion or metabolism and remaining provides nourishment to the body. In the same way after delivery of fetus, the Prasad bhaga of ahara Rasa collected in the breast immediately forms stanya. Rasadhatu Kshaya often leads to Stanya Kshaya4. The prevalence of Stanyakshaya is increasing ranging from 23-63% in western countries and 45-53% in India. In Ayurveda many treatment modalities are explained for Stanyakshaya so, in present study Shatavari Churna and Musali churna are selected which is having properties like Guru, Snigdha Guna, Sheeta Virya and Kaphavardhaka. |