| CTRI Number |
CTRI/2025/03/083517 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effectiveness of the Lekhaniya Mahakashya Sidha Tail Matra Basti in the treatment of Pushpaghni (PCOS) |
|
Scientific Title of Study
|
A Clinical Study of Lekhaniya Mahakashya Sidha Tail Matra Basti in the management of Pushpaghni (PCOS) |
| 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 Kiran |
| Designation |
P. G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved
Dr S.R.Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7877321821 |
| Fax |
|
| Email |
pariharkiran96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof A Neelima |
| Designation |
Professor and HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
PG Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S.R. Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
P G Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7877321821 |
| Fax |
|
| Email |
pariharkiran96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institue of Ayurved Dsrrau Jodhpur |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur RAJASTHAN |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| dr kiran |
P G Deoartment of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur RAJASTHAN |
|
|
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 |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan |
PG Department of Prasuti Tantra evam Stri Roga Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur RAJASTHAN 342037 India
Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN |
7877321821
pariharkiran96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Post Graduate Instiute of Ayurved, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः Pradhan Karma | (Procedure Reference: charak samhita sutrasthan 4/16, Procedure details: Purvakarma (Pre-treatment procedu
Abhyanga (Specially over abdomen, back, buttocks, thighs) followed by
Swedana done to the patient
The patient should be in left lateral side drawing up the right leg &
straightening the left leg
Pradhana Karma (Treatment procedure)
The Sneha prescribed for Matra basti taken in 60 ml syringe.
Then the anal region & the K-90 catheter should be smeared with Sneha. Gently
probe the anal orifice with the index finger of the left hand & introduce the
catheter through it into the rectum.
Keep it in the same position, press the syringe with right hand with adequate &
uniform force. catheter should be released carefully when a little quantity of
Sneha remained inside the catheter.
Pashchata Karma (Post-treatment procedures):
The patient is kept lying on his back as long as it would take to count up to
hundred
The patient should be gently struck three times on each of the soles & over the
buttocks
)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients diagnosed cases of PCOS by the Rotterdam criteria
Age -16-40 years
The patients who are fit for the Matrabasti procedure will be considered for the study
|
|
| ExclusionCriteria |
| Details |
Adrenal or ovarian tumor
Thyroid dysfunction
Cushing syndrome
Hyperprolectinaemia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regular Ovulatory Menstrual Cycle |
Regular Ovulatory Menstrual Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
percentage improvement in hormonal assays
weight reduction as assessed by reduction in body weight bmi |
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)
|
25/04/2025 |
| 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
|
|
Brief Summary
|
A Clinical Study of Lekhaniya Mahakashya Sidha Tail Matra Basti in the management of Pushpaghni (pcos)Introduction Women being the root of progeny, at most care is needed to protect her from any ailments that affect her reproductive potential. Polycystic Ovarian Syndrome (PCOS) is a common female endocrine disorder with high prevalence of PCOS the incidence rate of 2.2% to 26% worldwide and in India ranges from 3.7-22.5% depending on the criteria used for diagnosis. SELECTION OF DRUG Lekhaniya Mahakashya Sidha Tail |