| CTRI Number |
CTRI/2024/07/071073 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To know the effect of Yoni shoolahara kashaya and syrup for the patients having lower abdominal pain during menstruation. |
|
Scientific Title of Study
|
Comparative Clinical Study on The Effectiveness of Yonishoolahara Kashaya and Syrup in Udavartini Yonivyapad (Primary Dysmenorrhoea) |
| 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 Kaveri Timmapur |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B.M Road, Thanniruhalla,Hassan. |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital.
BM Road, Thanniruhalla, Hassan.
Hassan
KARNATAKA
573201
India |
| Phone |
8310650875 |
| Fax |
|
| Email |
kaveritimmapur2553@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu M |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan. |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital.
BM Road, Thanniruhalla, Hassan.
Hassan
KARNATAKA
573201
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhuayu@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaveri Timmapur |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan. |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital.
BM Road, Thanniruhalla, Hassan.
Hassan
KARNATAKA
573201
India |
| Phone |
8310650875 |
| Fax |
|
| Email |
kaveritimmapur2553@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital.
BM Road, Thanniruhalla,Hassan-573201 |
|
|
Primary Sponsor
|
| Name |
Kaveri Timmapur |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,BM Road,Thanniruhalla,Hassan.
BM Road, Thanniruhalla,Hassan-573201 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kaveri Timmapur |
Sri Dharmasthala Manjunatheswara Ayurveda Hospital,Hassan |
Department of Prasuti tantra and striroga, OPD number-20. SDM College of Ayurveda and Hospital, BM Road, Thanniruhalla,Hassan. 573201
Hassan
KARNATAKA |
8310650875
kaveritimmapur2553@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, Hassan. |
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 | Classical | | (1) Medicine Name: Yonishoolahara syrup, Reference: Sahasrayogam English translation by Dr.K.Nishteswar and Dr.R.Vaidyanath.Chapter 10-Parishishta Prakarana,108th preparation, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Syrup will be given 7 days prior to menstruation and first 3 days during menstruation | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yonishoolahara Kashaya, Reference: Sahasrayogam English translation by Dr.K.Nishteswar and Dr.R.Vaidyanath.Chapter 10-Parishishta Prakarana,108th preparation, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Kashaya will be given with equal amount of sukoshna jala with Madhu as anupana for 10 days (7 days prior to menstruation and first 3 days of menstruation) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Pain begins before one or two days of menstruation or with onset of menstruation and lasting for 1 to 2 days.
2) Spasmodic type of pain which is confined to lower abdomen or radiates to back and medial aspects of thighs.
3) With or without associated symptoms: Nausea, vomiting, diarrhea, headache, constipation, giddiness and fatigue.
4) Painful menstruation for at least previous 2 consecutive cycles.
5)Subjects with regular menstrual cycles.
6)Subjects willing to sign the written consent. |
|
| ExclusionCriteria |
| Details |
1)Known cases of Secondary dysmenorrhea with underlying pelvic pathology diagnosed by USG like Pelvic inflammatory disease, fibroids, endometriosis.
2)Subjects with intrauterine contraceptive devices.
3)Subjects on hormonal therapy.
4)Known cases of Congenital anomalies of reproductive system.
5)Known cases of Diabetes mellitus. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in lower abdominal pain during menstruation |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in lower abdominal pain in successive cycles with associated symptoms |
3 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Studies from India reported that primary dysmenorrhea prevalence ranges between 50 to 87.8%. Even though the prevalence rate is high it is often poorly treated. Udavartini yonivyapad is one of the Vataja yonivyapad among twenty Yonivyapad described by various Acharyas. Improper diet, mode of life and suppression of natural urges are the main causes of Udavartini yoni vyapad. According to Acharya Charaka, one feels relief after proper flow of menstrual blood. It upholds the similarity of udavartini with primary dysmenorrhea. Primary dysmenorrhea is defined as spasmodic pain in the lower abdomen occurring just before or during menstruation, in the absence of any pathology. Apanavata plays a major role in normal menstruation, Apanavata dushti which may cause vimarga gamana of vata leads to painful menstruation. So vatanulomaka and vatashamaka drugs may help in treating such condition. Previously many studies have been done on Udavartini yoni vyapad by using many procedures, oral medications. Thus “Yonishoolahara kashaya†mentioned in Sahasrayoga contains only few number of drugs which are easily available, cost effective and having vatashamaka properties is selected for the study which is also compared with syrup form to make it more palatable. |