| CTRI Number |
CTRI/2024/05/067374 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating the efficacy of Kashmaryadi Ghrit in the management of Udavartani yonivyapad (Dysmenorrhoea) |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of kashmaryadi Ghrit in the management of udavartani yonivyapad (Dysmenorrhoea) |
| 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 Prabha kumari |
| Designation |
Assistant professor, Head of department |
| Affiliation |
Government Ayurvedic college and Hospital, patna |
| Address |
Department of Prasuti tantra evum Stri roga, Government Ayurvedic college and hospital kadamkuan Patna
Aryabhatta knowledge university,patna
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta kumari |
| Designation |
PG Scholar (Prasuti evum Stri Roga) |
| Affiliation |
Government Ayurvedic college and Hospital, patna |
| Address |
Department of Prasuti tantra evum Stri roga, Government Ayurvedic college and hospital kadamkuan Patna
Aryabhatta knowledge university,patna
Patna
BIHAR
800003
India |
| Phone |
7766846004 |
| Fax |
|
| Email |
mamtakumari20dec1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta kumari |
| Designation |
PG Scholar (Prasuti evum Stri Roga) |
| Affiliation |
Government Ayurvedic college and Hospital, patna |
| Address |
Department of Prasuti tantra evum Stri roga, Government Ayurvedic college and hospital kadamkuan Patna
Aryabhatta knowledge university,patna
Patna
BIHAR
800003
India |
| Phone |
7766846004 |
| Fax |
|
| Email |
mamtakumari20dec1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college and hospital kadamkuan Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College, Patna |
| Address |
Department of Prasuti evum Stri Roga , Government Ayurvedic College, Kadamkuan Patna |
| 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 Mamta Kumari |
Government Ayurvedic college and hospital kadamkuan Patna |
Department of Prasuti Tantra evum Stri Roga
Government Ayurvedic College kadamkuan Patna
Aryabhatta Knowledge University, bihar
Patna
BIHAR |
7766846004
mamtakumari20dec1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kashmaryadi Ghrit, Reference: charak chikitsa 30/52,53, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
The sign symptoms based on both Ayurvedic as well as Modern view.
The age group of patients will be between 15 to 45 years.
Regular menses |
|
| ExclusionCriteria |
| Details |
pregnant women
having diabetes, CKD, Hypertension,
Any chronic diseases like AIDS, Cancer, cardiac disease
Adenomyosis
Uterine Fibroid
Endometrial Polyp |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical study to evalauate the efficacy of kashmaryadi ghrit in the management of udavartini yovivyapad (dysmenorrhoea) |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the Ayurvedic and modern concept about udavartani yonivyapad(dysmenorrhoea) |
2 months |
|
|
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 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
Dysmenorrhoea is the greek terminology defined as painful menstruation of suficient magnitude so as to incapacitate day to activity it may categorise in two types primary and seconday Dysmenorrhoea. Primary Dysmenorrhoea is painful menses in women. Normal pelvic anatomy usually begin during adolscence . It is characterized by crampy pelvic pain beginning shortly before or at the onset of menses and lastly 1-3 days. |