| CTRI Number |
CTRI/2022/11/047213 [Registered on: 11/11/2022] Trial Registered Prospectively |
| Last Modified On: |
10/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate the effect of medicated Arka in Primary dysmenorrhea |
|
Scientific Title of Study
|
Clinical Study To Evaluate The Effect Of Udavarta Roga Nashaka Arka In Udavartini Yoni Vyapath (Primary Dysmenorrhoea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr ASWINI S |
| Designation |
PRELIMINARY MS(AYURVEDA) SCHOLAR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
DEPARTMENT OF
PRASUTI TANTRA AND STREE ROGA SRI DHARMASTHALA
MANJUNATHESHWARACOLLEGE OF AYURVEDA AND
HOSPITAL, HASSAN – 573201
DEPARTMENT OF
PRASUTI TANTRA AND STREE ROGA SRI DHARMASTHALA
MANJUNATHESHWARACOLLEGE OF AYURVEDA AND
HOSPITAL, HASSAN – 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9747418656 |
| Fax |
|
| Email |
aswinisiva29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MADHU M |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SRI DHARMASTHALA
MANJUNATHESHWARA COLLEGE OF
AYURVEDA AND
HOSPITAL,
B.M.ROAD,
THANNIRUHALLA,
HASSAN-573201
KARNATAKA
SRI DHARMASTHALA
MANJUNATHESHWARA COLLEGE OF
AYURVEDA AND
HOSPITAL,
B.M.ROAD,
THANNIRUHALLA,
HASSAN-573201
KARNATAKA
Hassan
KARNATAKA
573201
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhu.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ASWINI S |
| Designation |
PRELIMINARY MS(AYURVEDA) SCHOLAR |
| Affiliation |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
| Address |
SRI DHARMASTHALA
MANJUNATHESHWARA COLLEGE OF
AYURVEDA AND
HOSPITAL,
B.M.ROAD,
THANNIRUHALLA,
HASSAN-573201
KARNATAKA
SRI DHARMASTHALA
MANJUNATHESHWARA COLLEGE OF
AYURVEDA AND
HOSPITAL,
B.M.ROAD,
THANNIRUHALLA,
HASSAN-573201
KARNATAKA
Hassan
KARNATAKA
573201
India |
| Phone |
9747418656 |
| Fax |
|
| Email |
aswinisiva29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College Of
Ayurveda And Hospital, Hassan
|
|
|
Primary Sponsor
|
| Name |
Dr ASWINI S |
| Address |
PRELIMINARY MS(AYURVEDA) SCHOLAR DEPARTMENT OF
PRASUTI TANTRA AND STREE ROGA SRI DHARMASTHALA
MANJUNATHESHWARACOLLEGE OF AYURVEDA AND
HOSPITAL, 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 |
| DrASWINI S |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
DEPARTMENT OF PRASUTHI TANTRA AND STREE ROGA, OPD NO.20
B.M.ROAD,
THANNIRUHALLA,
HASSAN-573201
KARNATAKA
Hassan
KARNATAKA |
9747418656
aswinisiva29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NSTITUTIONAL ETHICS COMMITTEE,SRI DHARMASTHALA MA NJUNATHESHWARAC OLLEGE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: UDAVARTA ROGA NASHAKA ARKA, Reference: ARKA PRAKASHA, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: -SHARKARA), Additional Information: The patient shall be given Udavarta roga nashaka arka in standard dose of 10 ml with guda as anupana twice daily one hour before food, orally for a period of 10 days, that is 7 days prior to menstruation and, during first 3 days of menstruation in 2 consecutive cycles. |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients fulfilling the diagnostic criteria.
2.Age between 16-35 years
3.Painful menstruation for at least previous 2 consecutive cycles,
4.Patients with regular menstrual cycles.
5.Patient willing to sign the written consent
|
|
| ExclusionCriteria |
| Details |
1.Cases of Secondary dysmenorrhoea with underlying pelvic pathology diagnosed by USG like Pelvic inflammatory disease, fibroids, endometriosis.
2.Patient with intrauterine contraceptive devices
3.Patient’s on hormonal therapy
4.Patient with gastritis
5.Known case of HIV, HBsAg, VDRL.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see the reduction in the insensitive of pain
and associated symptoms |
On completion of 2nd cycles and 3rd cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
15/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/11/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Udavarthini yoni vyapath is one among the vataja yoni vyapath.Normal menstruation is the function of Apana vata therefore painful menstruation is considered as Apana vata dushti. As movement of vata is in reverse direction of the course of uterine contraction, the woman becomes afflicted with pain and discharges the menstrual blood with great difficulty that is tending in a reverse direction. Apana vata is having the function of nishkramana of artava and its vitiation will lead to Udavartini yoni vyapath.Nidana, Samprapthi and Rupa of Udavartini yoni vyapat can be well explained with the etiopathogenesis and clinical features of Primary dysmenorrhoea.Primary dysmenorrhea is painful menstruation without any underlying pelvic pathology associated with nausea, vomiting, headache, fatigue. Previously many studies have been conducted for the same condition on Shodhana karmas mainly Vasthi and other oral medications. Arka kalpana is a very unique form of medicine by its palatability, increased potency and reduced dose. So as we are searching for more convenient forms of medication, Udavarta roga nasaka arka mentioned in Arka prakasha is selected for present study. The drugs included are Trikatu, Pippali mula, Trivrut, Danti and Chitraka with Guda as Anupana, most of the drugs are Vatanulomana and Sulahara in action. |