| CTRI Number |
CTRI/2019/02/017707 [Registered on: 18/02/2019] Trial Registered Prospectively |
| Last Modified On: |
16/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Shool Prashman Dashemani Choorn im Udavartini Yoni Vyapad i.e. Dysmenorrhea or painful menstruation. |
|
Scientific Title of Study
|
Management of udavartini yoni vyapad (dysmenorrhea) with shoolprashmana dashemani & erand bhrusht haritaki, shunthi- a comparative clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Gupta |
| Designation |
Research Scholar |
| Affiliation |
IPGTRA |
| Address |
5th floor Department of Prasuti Tantra and Stree Roga Institutional Building IPGTRA Gujarat Ayurved University City B Division Jamnagar
Gujarat Ayurved University City B division Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9596306387 |
| Fax |
|
| Email |
gupta.arun9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof LP Dei |
| Designation |
Dean and Head of the Department PTSR |
| Affiliation |
IPGTRA |
| Address |
5th floor Department of Prasuti Tantra and Stree Roga Institutional Building IPGTRA Gujarat Ayurved University City B Division Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9106943729 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof LP Dei |
| Designation |
Dean and Head of the Department PTSR |
| Affiliation |
IPGTRA |
| Address |
5th floor Department of Prasuti Tantra and Stree Roga Institutional Building IPGTRA Gujarat Ayurved University City B Division Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9106943729 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGTRA |
| Address |
Gujarat Ayurved University, City B Division Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Arun Gupta |
Room no 7 OPD PTSR, IPGTRA HOSPITAL |
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT |
9596306387
gupta.arun9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IPGTRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erand Bhrusht Haritaki and Shunthi choorn |
5gm orally, twice a day before meals followed by luke warm water, for two months |
| Intervention |
Shool Prashman Dashemani Choorn |
5gm orally twice a day before meals with cows ghee followed by luke warm water, for two months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Both married and unmarried subjects chief complaint of cramping pain 1day or more prior to the onset of menstruation and during the menstruation along with other symptoms, pain along with scanty or irregular menses, hypothyroidism, PCOS |
|
| ExclusionCriteria |
| Details |
age less that 18 or more than 30 years, not willing to participate in the study, severe anemia, known case of acid peptic disease, peptic ulcer disease or gastro esophageal reflux, bleeding disorders, uncontrolled diabetes and hypertension, other severe systemic illnesses |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Pain score and menstrual distress symptoms with regularity of menses |
Every month at the onset of menstruation, for two consecutive month followed by one month follow up post trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the drug, improvement in the secondary causes of the dysmenorrhea. |
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 4 |
|
Date of First Enrollment (India)
|
19/02/2019 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomized comparative clinical trial to compare the efficacy of Shool Prashman Dashemani Choorn 5gm with Erand Bhrusht Haritaki and Shunthi Choorn in the management of the Udavartini Yoni Vyapad (Dysmenorrhea). Total 30 patients will be enrolled in the present study. selected patients will be divided into two groups on the basis of the computer generated randomization. In this study Shool Prashman Choorn 5mg with anupaan of cow’s ghee twice a day followed by luke warm water will be given in group A and Erand Bhrusht Haritaki and Shunthi Churn 5gm followed by luke warm water will be given to the patients in group B for 2 months. Post trial follow up for 1 month will be carried out. |