| CTRI Number |
CTRI/2024/03/063684 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Palashadi Yog Basti in Udavartini Yonivyapad W.S.R. to Primary Dysmenorrhea |
|
Scientific Title of Study
|
Clinical study to assess the efficacy of Palashadi Yog Basti in Udavartini Yonivyapad with special reference to Primary Dysmenorrhea |
| 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 Akanksha Anand Patange |
| Designation |
PG Scholar |
| Affiliation |
Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Kharghar |
| Address |
OPD NO.6 Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
3rd floor Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9527168667 |
| Fax |
|
| Email |
akankshapatange66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayura M Devadiga |
| Designation |
Assistant Professor |
| Affiliation |
Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Kharghar |
| Address |
OPD NO.6 Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
3rd floor Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8108103035 |
| Fax |
|
| Email |
dr.mayuramd2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Anand Patange |
| Designation |
PG Scholar |
| Affiliation |
Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Kharghar |
| Address |
OPD NO.6 Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
3ed floor Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9527168667 |
| Fax |
|
| Email |
akankshapatange66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Akanksha Anand Patange |
| Address |
OPD NO.6 Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai |
| 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 Akanksha Patange |
Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Kharghar |
OPD NO.6 Prasutitantra and Stri Roga Department,Dr. G.D.Pol Foundation,YMT Ayurvedic Medical College,Institutional Area,Sector 4,Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA |
9527168667
akankshapatange66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charaka samhita Siddhi Sthan 3/44-45, Procedure details: For 8 days, pre menses (Rutu vyatit kal), for 3 consecutive cycles)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.All post-pubescent girls with Primary Dysmenorrhea.
2.Patients of age group between 18-25years.
|
|
| ExclusionCriteria |
| Details |
1.Patients having any uterine anatomical deformity.
2.Patients having pelvic pathology like PID, Uterine fibroids, Endometriosis, Adenomyosis, Cervical stenosis, Myoma and Endometrial polyp.
3.Patients taking any hormonal therapy.
4.Patients having IUCD in utero.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Palashadi Yog Basti in Udavartini Yonivyapad |
The study will be conducted for 3 months.
Follow up - 8 days before menses 1st cycle,2nd cycle,3rd cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Palashadi Yog Basti in Udavartini Yonivyapad |
The study will be conducted for 3 months.
Follow up - 8 days before menses 1st cycle,2nd cycle,3rd cycle
|
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
18/03/2024 |
| 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 Yet Recruiting |
| 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
|
The current study aimed as Clinical study to assess the efficacy of Palashadi Yog Basti in Udavartini Yonivyapad with special reference to Primary Dysmenorrhea. Total 55 diagnosed patients of Udavartini Yonivyapad will be Taken for study. The symptoms of Udavartini Yonivyapad are pain in abdomen while menstruation, nausea, vomitting, loose motion, backache etc. Palashadhi Yog Basti will be given for 8 days in premenstrual period for 3 consecutive cycle. Assessment will be done at each cycle for 3 cycles. Assessment done on the basis of subjective criteria and WaLIDD score |