| CTRI Number |
CTRI/2020/11/028971 [Registered on: 06/11/2020] Trial Registered Prospectively |
| Last Modified On: |
05/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Between the Efficacy Of Guduchyadi Taila Uttarbasti and Dashmool Taila Uttarbasti in Udavarta Yonivyapad. |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study Of Efficacy Of Guduchyadi Taila Uttarbasti and Dashmool Taila Uttarbasti in Udavarta Yonivyapad. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Machindra Rakh |
| Designation |
PG student |
| Affiliation |
PDEAs college of ayurved and research center, Nigadi Pradhikaran,Pune |
| Address |
PDEAs college of ayurved and research center,third floor Prasutitantra Evum Streeroga Department,sector no 25,Nigadi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9130069900 |
| Fax |
|
| Email |
priyankamrakh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Vijay Jadhav |
| Designation |
HOD |
| Affiliation |
PDEAs college of ayurved and research center,Nigadi Pradhikaran,Pune |
| Address |
PDEAs college of ayurved and research center,third floor Prasutitantra Evum Streeroga department,sector no 25,Nigadi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9850808899 |
| Fax |
|
| Email |
anjalivijayjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Machindra Rakh |
| Designation |
PG student |
| Affiliation |
PDEAs college of ayurved and research center,Nigadi Pradhikaran,Pune |
| Address |
PDEAs college of ayurved and research center,third floor Prasutitantra Evum Streeroga department,sector No 25,Nigadi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9130069900 |
| Fax |
|
| Email |
priyankamrakh@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research center,nigdi pradhikaran,Pune 44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs college of ayurved and research centre |
| Address |
PDEAs college of ayurved and research centre,sector no 25,Nigadi Pradhikaran,Pune 44 |
| 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 Priyanka Machindra Rakh |
Ayurved rugnalaya and sterling multispeciality hospital nigadi pradhikaran pune |
Vitthal rukmini road sector no 27,Prasutitantra evum streeroga OPD 119,nigadi pradhikaran,Pune
Pune
MAHARASHTRA |
9130069900
priyankamrakh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONI-VYAPADA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dashmool taila uttarbasti |
Dashmool taila uttarbasti will be purchased from GMP certified pharmacy and uttarbasti will be given to females in the age group of 20-40 years in 5 ml matra for 3 consecutive days after cessation of menstrual bleeding for 3 consecutive menstrual cycles. |
| Intervention |
Guduchyadi taila uttarbasti |
Guduchyadi taila will be purchased from GMP certified pharmacy and uttar basti will be given to females in the age group of 20-40 years in 5 ml matra for 3 consecutive days after cessation of menstrual bleeding for 3 consecutive menstrual cycles. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients fulfilling the diagnostic criteria.
2.Patient age group between 20 to 40 years.
3.Patients with regular menstrual cycles(21-35days is the normal menstrual cycle).
4.Painful menstruation for at least 3 consecutive cycles.
5.Patient willingly participating in the trials and giving consent form
|
|
| ExclusionCriteria |
| Details |
1.Cases of Secondary dysmenorrhoea with pelvic pathology- Fibroid of Uterus, Ovarian cyst, Endometriosis, Endometrial hyperplasia.
2.Irregular menstrual cycle, metrorrhagia, menorrhagia.
3.Patient with IUCD.
4.Patients on hormonal therapy.
5.Patients having congenital anomalies leading to dysmenorrhoea.
6.Patients with systemic disease disorders like DM, HTN etc.
7.Antenatal and postnatal. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Guduchyadi taila uttarbasti and dashmool taila uttarbasti in udavarta yonivyapad for 3 consecutive days after cessation of menstrual bleeding. |
3 consecutive days after cessation of menstrual bleeding for 3 consecutive menstrual cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any adverse effect of Guduchyadi taila uttarbasti and Dashmool taila uttarbasti |
3 consecutive days after cessation of menstrual bleeding for 3 consecutive menstrual cycles. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 1 |
|
Date of First Enrollment (India)
|
15/11/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Dysmenorrhoea is one of the most common problem among gynaecological complaints.Dysmenorrhoea means painful menstruation.Its mostly confined to adolescent and almost confined to ovulatory cycle. Majority of cases fall in group of Primary Dysmenorrhoea and it is probably 60% and even more adult female population suffers from it.In Ayurvedic classics all gynaecological disorders are described under the umbrella of yoni vyapadas and Artava vikaras.As per symptoms shown in Udavarta yoni vyapada it can be compared with dysmenorrhoea. Ayurveda texts describes use of Guduchyadi taila and dashmool taila in vataj yonivyapad effectively . so I have selected this topic to study the efficacy of the guduchyadi taila and dashmool taila uttar basti in udavarta yonivyapada and to provide a good effective alternative to routinely prescribed medications now. |