| CTRI Number |
CTRI/2024/08/072251 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Vajrakanjika Yoga In Management Of Stanyakshaya |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Effect Of Vajrakanjika Yoga 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 |
DrKrishna Sharma |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda,Dr.S R Rajasthan Ayurveda University,Jodhpur,Rajasthan |
| Address |
P.G Department of Prasuti Tantra Evam Stri Roga Post Graduate
Institute of Ayurveda Dr.S R Rajasthan Ayurveda University,karwad,
Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8003218247 |
| Fax |
|
| Email |
ks8003218247@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAsha KP |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurveda,Dr.S R Rajasthan Ayurveda University,Jodhpur,Rajasthan |
| Address |
P.G Department of Prasuti Tantra Evam Stri Roga Post Graduate
Institute of Ayurveda Dr.S R Rajasthan Ayurveda University,karwad,
Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9995917339 |
| Fax |
|
| Email |
dr.ashakp07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKrishna Sharma |
| Designation |
MS Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda,Dr.S R Rajasthan Ayurveda University,Jodhpur,Rajasthan |
| Address |
P.G Department of Prasuti Tantra Evam Stri Roga Post Graduate
Institute of Ayurveda Dr.S R Rajasthan Ayurveda University,karwad,
Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8003218247 |
| Fax |
|
| Email |
ks8003218247@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda ,Jodhpur,Pincode 342037,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda ,Jodhpur Rajasthan |
| Address |
Post Graduate Institute of Ayurveda ,Dr.Sarvapalli Radha Krishnan
Rajasthan Ayurveda University,Nagaur Road ,Karwad,Jodhpur
,Rajasthan,342037,India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrKrishna Sharma |
Post Graduate Institute of Ayurveda
,Dr.Sarvapalli Radha Krishnan Rajasthan
Ayurveda University,Nagaur Road
,Karwad,Jodhpur ,Rajasthan,342037,India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Sharma |
Post Graduate Institute of Ayurved, Jodhpur, Rajasthan |
P.G Department of
Prasuti Tantra evam
Stri Roga(OPD no-5),
Post Graduate Institute
of Ayurved, Dr.
Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University, Nagaur
Road, Karwad,
Jodhpur, Rajasthan
342037 India Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
8003218247
ks8003218247@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institute of Ayurved, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O925||Suppressed lactation. Ayurveda Condition: STANYAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vajrakanjika Yoga, Reference: Yog Ratnakar Ksheerdosha Chikitsa, Route: Oral, Dosage Form: Arishta, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Age group between 18 to 40 years irrespective to religion, socio-economic status and food habits.
2.Patients from 5th day of delivery.
3.Patients with previous history of lactation deficiency.
4.Breast feeding frequency less than 4-5 times/day.
5.Patient having baby of less than 6 month of age, partially or totally on top feed.
6.Patient’s baby birth weight more than or equal to 2.5 kg.
7.Patient’s delivery should be at full term.
8.Patients either of Primigravida or Multigravida will be selected.
|
|
| ExclusionCriteria |
| Details |
1.Patient with congenital anomalies of breast (absence of nipple or the breast tissue).
2.Patient with breast atrophy and inverted nipple, mastitis, breast abscess.
3.Patient with known case of immune compromised disease like AIDS, Cancer.
4.Patients having H/o alcoholism and smoking.
5.Patient with known case of systemic disease like Diabetes mellitus & thyroid dysfunction.
6.Patient’s baby with congenital anomalies (cleft lip, cleft palate), birth trauma, premature birth.
7.Patient who is taking anti prolactin drug (bromocriptine, cabergoline) which suppress lactation.
8.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 enhance milk production and improvement of serum prolactin level.
|
60 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To increase baby’s weight. |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/08/2024 |
| 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="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
|
This is a single group ,open label clinical study to evaluate the effect of Vajrakanjika Yoga in the management of Stanyakshaya .Vajrakanjika Yoga is mainly having Katu, Tiktha, Kashaya Rasa, Ushnavirya, Madhura Katu Vipaka Dravyas and act on Rasavahisrotas and Rasagni. Being Ushna in Virya these are Uttejaka (stimulant), Agnivardhaka, Deepana-Paachana, Srotosodhaka, Shothaahara, Vatanulomaka, and being Madhura in Vipaka are Vrishya, Rasayana, Dhatuvardhaka. Drugs like Kanji, Pippali, Pippalimoola, Chavya, Shweta and Krishna Jeeraka, Sovarchala lavana and Vida lavana having Deepana, Pachana and act as Rasa Dhatu Vardhaka, Balyakara, Dhatuposhaka, corrects Agnimandya, which in turn improves Rasa Dhatwagni which helps for Stanya Utpatti. Also, these Dravyas being Srotoshodhaka, clear the obstruction in Stanavahasrotas and thus ease the process of galactokinesis. |