| CTRI Number |
CTRI/2021/03/032219 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Punarnavadi Guggulu as a treatment of symptoms occuring before menses |
|
Scientific Title of Study
|
Open Labeled Single Arm Clinical Trail on Punarnavadi Guggulu in the management of Premenstrual Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha Rathore |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room no. 308 Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurveda Parul University P O Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9826962839 |
| Fax |
02668-260201 |
| Email |
rmegha137@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjusha Karkare |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room no. 308 Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurveda Parul University P O Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9422515717 |
| Fax |
02668-260201 |
| Email |
mrkarkare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjusha Karkare |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
Room no. 308 Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurveda Parul University P O Limda Tal Waghodia Vadodara Gujarat
GUJARAT
391760
India |
| Phone |
9422515717 |
| Fax |
02668-260201 |
| Email |
mrkarkare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurveda Hospital, Parul University, Vadodara, 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurvda |
| Address |
OP no 104 department of prasuti tantra evum stree roga Parul Institute of Ayurveda Parul University PO Limda Tal Waghodia Vadodara Gujrata |
| 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 |
| Dr Manjusha Karkare |
Parul Ayurveda Hospital |
Room no 308 Department of Prasuti Tantra Evum Stree Roga Parul Institute of Ayurveda Parul University P O Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT |
9422515717
02668-260201
mrkarkare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:Z659||Problem related to unspecified psychosocial circumstances. Ayurveda Condition: not specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Punarnavadi Guggulu |
4 tablets (500 mg each) twice a day with luke warm water After meal for 2 cycles and one cycle will be observed without intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age 18-40 years
Irrespective of marrital status
Regular cycle
Symptoms should appear at definite time in luteal phase of the cycle |
|
| ExclusionCriteria |
| Details |
Women aged below 18 and above 40 years
Diagnosed psychiatric disorder
Irregular cycle
Any organic pelvic pathology
Any known major systemic illness
Diabetes PCOS Metrorrhagia
symptoms should not persist after 5 days of menstrual cycle
symptoms shuold not reoccur within the 1st 13 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To subside premenstrual symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relief in the symptoms of dysmenorrhea |
30 days |
|
|
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)
|
26/03/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be done after the completion of trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premenstrual syndrome (PMS) encompasses a variety of emotional and physical symptoms that occur from several days to weeks before the onset of menstrual flow. Presently, Premenstrual syndrome is recognized as a psycho-neuroendocrine disorder of unknown etiology. Symptoms disrupting the premenstrual period if left untreated may lead to PMDD-premenstrual dysphoric disease which is a more severe form of manifestation of the symptoms related to PMS may have disastrous effects in the form of suicidal thoughts, panic disorders, lack of interest in daily activities and relationships. This may have grave consequences on the socio-economic of life thereby reducing the qualiy of life of the patient. Modern medicine has not zeroed in on a specific cause, but has suggested a number hypothesis to explain the possible pathophysiology. They are as under: Diminished progesterone levels, Decreased synthesis of serotonin, Withdrawal of endorphins from the brain during luteal phase, Reduced Gamma amino butyric acid levels. By and large symptoms complex bears a similarity to the Samprapti of Shotha mentioned by Ayurvedic classics. The hypothesis therefore is formed that the drugs used in Shotha vyadhi would be helpful in terminating the Samprapti and alleviating the symptoms in PMS. The hypothesis is substantiated by the fact that the intervention drug chosen for this study- Punarnavadi guggulu from Shotha-adhikara of Bhaishajya Ratnawali is indeed found to be useful in treating PMS. It is therefore proposed to undertake this study to create an evidence for its usage by vaidyas. Assessment criteria- PMTS-OR Intervention - Punarnavadi Guggulu 4 tab (500mg each) twice a day with luke warm water, After meal, for 2 cycles and 1 cycle for observation
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