| CTRI Number |
CTRI/2019/09/021241 [Registered on: 13/09/2019] Trial Registered Prospectively |
| Last Modified On: |
12/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY ON AYURVEDA MEDICINES - MISHREYA CHOORNA (FENNEL POWDER) AND ASHWAGANDHA CHOORNA(Powdered root of WITHANIA SOMNIFERA) IN MENTAL SYMPTOMS OF PREMENSTRUAL SYNDROME. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE MISHREYA CHOORNA AND ASHWAGANDHA CHOORNA IN PSYCHOLOGICAL SYMPTOMS 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 Saumyalakshmi S |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department Of Manovigyana evam Manasaroga
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
08217486934 |
| Fax |
|
| Email |
drsoumyalakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSavithaHP |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department Of Manovigyana evam Manasaroga
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
09980168208 |
| Fax |
|
| Email |
drsavithahp@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saumyalakshmi S |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department Of Manovigyana evam Manasaroga
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
08217486934 |
| Fax |
|
| Email |
drsoumyalakshmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
|
| Type of Sponsor |
Private 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 Saumyalakshmi S |
Sri Dharmasthala Manjunatheshwara Ayurveda hospital |
Opd no: 4,
Dept of Manovigyan evum Manasaroga
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA |
08217486934
drsoumyalakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ashwagandha choorna(Powder of Withania somnifera) |
Ashwagandha choorna(Powder of Withania somnifera)-3 gms BD orally administered with 50 ml milk after food for three consecutive months. |
| Intervention |
Mishreya choorna(Powder of Feoniculum vulgare- FENNEL) |
Mishreya choorna(Powder of Feoniculum vulgare- FENNEL)-3 gm BD Orally administered with 50ml Milk after food for three consecutive months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Female subjects with regular menstrual cycle since 3 months.
2.Age between 18 years of age to 40 years of age irrespective of socio economic status and in good medical health.
3.The subjects who are ready to follow the treatment protocol and sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1.Those with symptoms existing less than three cycles.
2.Subjects having diabetes mellitus, hypertension, PCOS, DUB.
3.Subjects suffering from other acute and chronic psychiatric illnesses
4.Subjects suffering from organic brain diseases.
5.Subjects under hormonal and psychiatric treatment.
6.Subjects taking Oral Contraceptive Pills.
7.Subjects with Premenstrual Dysphoric disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFECT OF MISHREYA CHOORNA IN COMPARISON TO ASHWAGANDHA CHOORNA IN PSYCHOLOGICAL SYMPTOMS OF PREMENSTRUAL SYNDROME |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Somatic symptoms of premenstrual syndrome. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT PUBLISHED YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open label, double arm, exploratory
clinical study comparing the efficacy of Mishreya choorna 3gmBD daily and
Ashwagandha choorna 3gm BD daily for three
months in 40 patients with Premenstrual syndrome. The study is conducted in Hospital attached
to Ayurveda medical college with laboratory facilities. The primary outcome
measure reduction in Premenstrual Syndrome score after 90 days of trial. |