| CTRI Number |
CTRI/2024/08/071834 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of artava kshaya (pcos) i.e. anovulation, oligomenorrhea , polycystic ovaries. |
|
Scientific Title of Study
|
An exploratory single arm study on the efficacy of maha agad in the management of dushi visha janya artava kshaya (poly cystic 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 |
Dr Sristi Purohit |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9783143212 |
| Fax |
|
| Email |
sristipurohit4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976967729 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Kapoor |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurved Jodhpur 342037 |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved jodhpur RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976967729 |
| Fax |
|
| Email |
drritukapoor4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Jodhpur 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur |
| Address |
PG Department of Agad Tantra Post Graduate Institute of Ayurved jodhpur RAJASTHAN |
| Type of Sponsor |
Government medical 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 Sristi Purohit |
Post Graduate Institute of Ayurved Jodhpur |
PG department of Agad
tantra Post graduate
institute of ayurved
jodhpur 342037
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9783143212
sristipurohit4@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:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MAHA AGAD, Reference: Ashtang Sangrah Uttarsthan42/50, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: 2 tab each of 500mg tds would be given to the patient. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient diagnosed cases of PCOS by the ROTTERDAM CRITERIA.
2. Patient with age group between 18-45 years.
3. Patient willing to give consent for clinical trial.
4. Patient having history of consuming Dushi Visha (as per mentioned in questionnaire) for a long period of time.
|
|
| ExclusionCriteria |
| Details |
1. Patient suffering from adrenal or ovarian tumor.
2. Patient suffering from cushing syndrome, congenital adrenal hyperplasia, hyperprolactinemia.
3.Patient suffering from any systemic disorder and congenital disorder.
4.Patient suffering from pelvic pathology including fibroid uterus, cervical polyp.
5.Women taking oral contraceptive pills
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of ovarian cyst (size, volume & number).
|
60 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the secondary objective.
1. Improvement in hormonal assay.
2.Attainment of normal menstrual cycle.
3. To reduce pelvic pain.
4. Weight reduction accessed by 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)
|
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="0"
Months="10"
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
|
Type of study : Interventional Purpose : Treatment Timing : Prospective End point : Effectiveness/Therapy Duration : 60 days Sample size : 30 CRITERIA FOR SELECTION : Patients will be selected from OPD and IPD of PGIA, Jodhpur and registered dispensary/hospital asper the criteria of inclusion strictly. • Written voluntary informed consent will be obtained from each patient before starting the trial. The study will be completed on minimum 30 clinically diagnosed patients of PCOS. POSOLOGY: Maha Agad Kalpana -Vati Dose -2 Tab of 500 mg Route of administration- Orally Time of administration- 3 times a day after meal Anupana -Luke warm water Duration- 60 days FOLLOW UP STUDY 1. Follow up after 15 days completion of the trial will be in 60 days. 2. Improvement and other effect will be noted. 3. Laboratory investigations will be repeated if seemed necessary.
|