| CTRI Number |
CTRI/2024/06/069634 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of 60ml Sahacharadi Taila Matra Basti in The management of PCOD |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Combined Efficacy Of Sahacharadi Taila Matra Basti with Oral Administration OF Shatpushpa Churna In The Management Of Artavkshaya Due To Polycystic Ovarian Syndrome
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashvini Diliprao Zore |
| Designation |
PG scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya118/119 shukrawar peth near juni faujdar chawdi solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
8830651470 |
| Fax |
|
| Email |
ashuzore14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashvini Diliprao Zore |
| Designation |
PG scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
8830651470 |
| Fax |
|
| Email |
ashuzore14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashvini Diliprao Zore |
| Designation |
PG scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyalaya |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur
Solapur
MAHARASHTRA
413002
India |
| Phone |
8830651470 |
| Fax |
|
| Email |
ashuzore14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukravar Peth Near juni Faujdar Chavdi Solapur |
|
|
Primary Sponsor
|
| Name |
Dr Ashvini Zore |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalay 118/119 Shukravar Peth Near juni Faujdar Chawdi, Solapur |
| Type of Sponsor |
Other [Other ( Gov Grant In Aid Ayurveda College] |
|
|
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 |
| Dr Veena Jawale |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
OPD nuber 4 Seth Sakharam Nemchand Jain Ayurved Rugnalaya 118/119 Shukravar Peth Near juni Faujdar Chavdi
Solapur
MAHARASHTRA |
8830651470
veena.jawale@sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E888||Other specified metabolic disorders. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Basti, Procedure details: Matra basti)
(1) Medicine Name: Sahacharadi Taila , Reference: 60ml, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Subject of age group 18 to 35 years irrespective of marital status
Subject fulfilling diagnosis criteria
Amenorrhoea for more than 35 days to 60 days |
|
| ExclusionCriteria |
| Details |
Subject with primary Amenorrhoea
Subject having any acute infection or any systemic major disease
Pregnancy
Subject who are Basti Anarha according to Ayurveda |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the efficacy of Sahacharadi Taila Matrabasti with oral administration of Shatapushpa Churna in the management of Artavkshaya due to PCOS |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the change in ovarian volume.
To determine the change in number of follicules |
Assessment will be done on every 8th day of 1"/2nd/3d menstrual cycle |
|
|
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 1 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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="0"
Months="11"
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
|
Article not yet published |