| CTRI Number |
CTRI/2024/05/067477 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study The Effect Of Ayurvedic Formulation In Artavkshaya (scanty menses) |
|
Scientific Title of Study
|
A Single Arm Clinical Study To Evaluate The Efficacy Of Ayurvedic Formulation In Artavkshaya |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jethva Shivangiben |
| Designation |
MS Scholar |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research Centre |
| Address |
OPD 2, Stree Roga and Prasuti Tantra Department, Dr. D. Y. Patil college of Ayurveda and Research Centre, Sant Tukaram Nagar, Pimpri, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9824911923 |
| Fax |
|
| Email |
shivangijethva99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Patil |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre |
| Address |
OPD 2, Stree Roga and Prasuti Tantra Department, Dr. D. Y. Patil college of Ayurveda and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Patil |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre |
| Address |
OPD 2, Stree Roga and Prasuti Tantra Department,Dr. D. Y. Patil college of Ayurveda and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9921244690 |
| Fax |
|
| Email |
jayupa.patil6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
|
|
|
Primary Sponsor
|
| Name |
Jethva Shivangiben |
| Address |
Opd no 2 Stree roga and Prasuti tantra department Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
|
| Type of Sponsor |
Other [Self] |
|
|
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 Jethva Shivangiben |
Dr D Y Patil college of Ayurved and Research centre Sant Tukaram Nagar Pimpri Pune |
OPD and IPD Stree roga and Prasuti tantra Department Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
9824911923
shivangijethva99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpas muladi churna, Reference: Bhavprakash Guduchyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -Karpasmuladi churna which is three ingredients karpas mula, garjar beeja, Krishna tila in churna form |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Duration of Menstrual bleeding flow of 2 days or less
Patient with reduced quantity of menstrual flow
Patient with increased intermenstrual period more than 35 days
Age group of female between 20 to 40 years will be selected (Inclusive both years) |
|
| ExclusionCriteria |
| Details |
Women Suffering with gross structural abnormalities of uterus and overy.
Systemic illness like Diabetes Mellitus, Thyroid function, Hypertension, any type of malignancy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Ayurvedic Formulation in management of Artavkshaya |
60 days before menstrual cycle upto 1st day of during menstrual cycle for 2 consecutive menstrual cycles
(Follow up for 2 consecutive menstrual cycles) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Observe The Adverse Effect of Ayurvedic Formulation in Artavkshaya If Any |
60 days before menstrual cycle upto 1st day during menstrual cycle for 2 consecutive menstrual cycles
(Follow up for 2 consecutive menstrual cycles) |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2024 |
| 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="6"
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 Arm clinical Study. The Aim Of Study to Evaluate The Efficacy of Ayurvedic Formulation in Artavakshaya.Total 40 Patients will be enrolled and 3 gm Ayurvedic Formulation in Churna form will be given orally twice a day after meal with Luke warm water. The age group taken for this study is 20 to 40 years of female. |