| CTRI Number |
CTRI/2021/05/033405 [Registered on: 05/05/2021] Trial Registered Prospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ashiposhak vati for Premenstrual syndrome |
|
Scientific Title of Study
|
Open labeled interventional clinical trial to evaluate effect of Asthipohak Vati tablet in the management of Premenstrual Syndrome(PMS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Patel |
| Designation |
Director Medical and Paramedical |
| Affiliation |
Parul University |
| Address |
Parul Sevashram hospital
Parul Universiity
PO Limda Waghodia
same as above
Vadodara
GUJARAT
391760
India |
| Phone |
9825469544 |
| Fax |
02668260201 |
| Email |
drkomal@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Karkare |
| Designation |
Professor |
| Affiliation |
Parul institute of Ayurveda |
| Address |
Opd no 104 Parul Ayurved Hospital
Parul Institute of Ayurveda
Parul University
Limda-Waghodia
Vadodara
same as above
Vadodara
GUJARAT
390019
India |
| Phone |
09422515717 |
| Fax |
02668260201 |
| Email |
mrkarkare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asokan V |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Opd no 104 Parul Ayurved Hospital
Parul Institute of Ayurveda
Parul University
Limda-Waghodia
same as above
Vadodara
GUJARAT
390019
India |
| Phone |
6361740431 |
| Fax |
02668260201 |
| Email |
asokan.v260043@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Shree Dhootpapeshwar Ltd |
| Teaching Hospital of Parul Institute of Ayurveda and
Khemdas Ayurveda Hospital |
|
|
Primary Sponsor
|
| Name |
Shree Dhootpapeshwar Ltd |
| Address |
Shree Dhootpapeshwar ltd.
135 Nanubhai Desai Road, Khetwadi
Mumbai 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mauli Vaishnav |
KhemdasAyurveda Hospital |
Ishverpura, Vadodara 391760
Vadodara
GUJARAT |
9589788336
mauli.vaishnav86211@paruluniversity.ac.in |
| Dr Manjusha Karkare |
Parul Ayurveda Hospital |
Vadodara Gujrath, 391760
Vadodara
GUJARAT |
9422515717
02668260201
mrkarkare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Human Research |
Approved |
| Institutional Ethics committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E35||Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: Pre-menstrual syndrome, (2) ICD-10 Condition:E34||Other endocrine disorders. Ayurveda Condition: Pre-menstrual syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asthiposhak vati |
2 tablets orally twice a day with milk or water after food for 60 days
Follow up 30 days |
| Comparator Agent |
not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Subjects irrespective of their marital status
2 Women with regular cycle with symptoms of pre- menstrual syndrome, at around 25th day onwards of menstrual cycle, with symptoms extending not beyond 5th day of subsequent menstrual cycle.
3 Women having a minimum PMTS score greater than or equal to 10 and VAS score greater than or equal to 1
4 Be able and willing in the view of the investigator to comply with all study procedures
|
|
| ExclusionCriteria |
| Details |
1 Subjects aged above 40 years
2 Unmarried or married subjects with irregular cycles
3 Pregnant women
4 Subjects on any type of OC Pills hormone containing medication since past 6 months IUCD ovulation induction or menstrual regularizers-since past 6 months
5 Subjects with chronic debilitating ailments and on cortico steroid therapy
6 Women with history of PID endometriosis and debilitating pathological conditions of the pelvic organs systemic diseases like diabetes mellitus bronchial asthma tuberculosis thyroid dysfunction with organic lesion benign or malignant growth of reproductive tract any degree of uterine prolapse and hypo-plastic uterus
7 Women with congenital anomalies of genital organs
8 Subjects with history of or diagnosed cases of psychosomatic ailments, Cognitive disorders, psychosis or neurosis, personality disorders
9 Women with Urinary calculus
10 Women taking any concomitant medicine for PMS will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the clinical features and relief of PMS |
The outcomes will be measured after screening at Base Line (BT) after 1 month and at the end of 2 months AT Assessment of clinical parameters will also be done at the end of the 3rd month after 1 month of medicine free period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in pain in premenstrual period
Improvements in low back ache constipation
|
The outcomes will be measured after screening at Base Line BT after 1 month and at the end of 2 months AT Assessment of clinical parameters will also be done at the end of the 3rd. month after 1 month of medicine free period |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/05/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premenstrual syndrome is recognized as a psycho-neuro-endocrine disorder of unknown aeitiology PMS encompasses a wide variety of emotional and physical symptoms that occur from several days to week before the onset of menstrual flow. Various hypotheses are postulated to explain the etiopathogenesis of PMSEvidence strongly suggests that calcium and vitamin D deficiency and alteration in the metabolism of calcium and vitamin D are responsible for these luteal phase symptoms In the present study propreitary medicine asthiposhak vati which is known to relieve symptoms related to calcium deficiency, is selected for the management of PMS It may have a positive effect on the calcium metabolism and thereby alter the pathology of PMS. Patients will be asses ed on the basis of 1 PMS self rating scale 2.PMS Observer rating scale 3. PMS Vas scale |