| CTRI Number |
CTRI/2025/09/094337 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral medication for Dysmenorrhea patients for treating Pain in lower abdomen during Periods |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study To Evaluate The Effect Of Streepriyadi Kwatha In Udavartini Yoni Vyapath w.s.r To 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 SHREEVALLI P |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi-574118
Department of PG and P.H.D Studies in Prasootitantra Evam Streeroga.
Udupi KARNATAKA 574118 India |
| Phone |
9113829315 |
| Fax |
|
| Email |
shreevallip02@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SUCHETHAKUMARI |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI
DEPARTMENT OF PG AND P.H.D STUDIES IN PRASUTITANTRA EVAM STREEROGA
Udupi KARNATAKA 574118 India |
| Phone |
9448529574 |
| Fax |
|
| Email |
suchetha.sdm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SUCHETHAKUMARI |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
| Address |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI
DEPARTMENT OF PG AND P.H.D STUDIES IN PRASUTITANTRA EVAM STREEROGA
KARNATAKA 574118 India |
| Phone |
9448529574 |
| Fax |
|
| Email |
suchetha.sdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shreevalli p PG Scholar Department of PG and PHD Studies in Prasootitantra evam Streeroga Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi 574118 |
|
|
Primary Sponsor
|
| Name |
Dr Shreevalli p |
| Address |
Srivari Nilaya
Shankarapuram 4th cross B.H Road
Tumakuru 572103
Karnataka |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SUCHETHAKUMARI |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTRE KUTHPADY UDUPI -574118 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHREEVALLI P |
Sri Dharmasthala Manjunatheshwara Hospital |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre Kuthpady Udupi Department of PG and PHD Studies in Prasutitantra Evam Streeroga Udupi KARNATAKA |
09113829315
shreevallip02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE -HUMAN SDMCAU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: STREEPRIYADI KWATHA, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Spasmodic type of pain which is confined to lower abdomen or radiates to back and medial aspect of thighs.
2 Subjects with painful menstruation for atleast 2 consecutive cycles.
3 Known case of Secondary dysmenorrhea with underlying pelvic pathology uterine fibroids Adenomyosis endometriosis.
4 Patients of age between 18-40yrs
|
|
| ExclusionCriteria |
| Details |
1 Subjects with hormonal therapies
2 Known case of congenital anamolies of reproductive system.
3 HB% is less than 6.5gm%.
4 Subjects with intrauterine contraceptive devices.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Effect of Streepriyadi Kwatha In Udavartini Yoni Vyapath w.s.r to Dysmenorrhea |
10 Days of 2 Consecutive Cycles
Follow Up On 5th Day Of Succesive 3rd Cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duaration of pain,site of pain,intensity of pain is together assessed by WaLIDD Scores. |
10 Days For 2 Consecutive Cycles
Follow Up on 5th Day of Succesive 3rd Cycle |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
25/09/2025 |
| 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="0" Months="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Menstruation is a normal physiological process
where every women undergo in their life time.During menstruation there will be lot of physical and
psychological changes.One
such aspect is painful menstruation called as Dysmenorrhea which can be
considered as Udavartini yoni vyapad.Udavartini is one among the twenty Yoni vyapath described by various Acharyas which is characterized by ‘Rajah krichrena munchathi’-discharge
of menstrual blood with great difficulty, There will be immediate relief from
pain following discharge of menstrual blood.The
word dysmenorrhea is derived from greek origin and means difficult monthly flow
but now it is taken to mean painful menstruation.Cyclic
pain with menstruation is common and accompanies most menses(Weissman,2004).The
pain is classically described as cramping and is often accompanied by low back
ache,nausea andvomiting,headache
or diarrhea. Prevalence of dysmenorrhoea world wide ranges
15.8-89.5% with a higher prevalence in adolescent girls.Prevalence of dysmenorrhea in adolescent girls are found to be
79.67%.Most of them 37.96% suffered regularly from dysmenorrhea severity.Dysmenorrhea incidence of 33.5% was reported
by Nag (1982) among adolescent girls in India. A study done in Sweden showed
that more than 50% of all menstruating women experience some discomfort. It has
also been reported by a senior obstetrician that probably 5 – 10% of girls in
their late teens suffer from severe spasmodic dysmenorrhea interrupting their
educational and social life.Unlike primary dysmenorrhea,reports of
secondary dysmenorrhea tend to increase with age,it is reported most often in
women aged 30-45yrs.Since dysmenorrhea will be haunting women with their daily day to day
activites and no such complete remedies are available in contemporary
science.It is need of the hour to utilize Medicines told in Ayurveda and folklore which has so many
magical remidies and timetested . Streepriyadi kwatha is one such folklore
formulation and Ashoka ,one of the ingredient of it is mentioned in ayurvedic classical text like charaka
samhitha with its well known effective action in pain management.The practice of Ayurveda and folklore medicine has always went in hand by hand.In
folklore practices there are so many effective remedies which are yet to be
explored and need scientific authentication.The knowledge of folklore medicine
is being a treasure.In this regard to mimimize the challenges
faced during the painful menstruation,using the treasurable knowledge by Ayurveda and folklore sciences this
study is taken up.
|