CTRI Number |
CTRI/2020/04/024766 [Registered on: 21/04/2020] Trial Registered Prospectively |
Last Modified On: |
11/04/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Medical Device Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial on Ayurveda therapies in cervical erosion |
Scientific Title of Study
|
A Randomized open label comparative clinical study of Agnikarma and Virechana karma in the management of Karnini yonivyapad with special referance to Cervical Erosion |
Trial Acronym |
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Secondary IDs if Any
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Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrPratima |
Designation |
MS Scholar |
Affiliation |
National Institute of Ayurveda, Jaipur |
Address |
Department of prasuti tantra
National Institute of Ayurveda Madhav Villas Palace
Jorawar Singh Gate
Amer road
Jaipur
Jaipur RAJASTHAN 302020 India |
Phone |
9669468199 |
Fax |
|
Email |
chotiprasad@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr B Pushpalatha |
Designation |
Associate Professor |
Affiliation |
National Institute of Ayurveda, Jaipur |
Address |
Department of prasuti tantra
National Institute of Ayurveda Madhav Villas Palace
Jorawar Singh Gate
Amer road
Jaipur
Jaipur RAJASTHAN 302002 India |
Phone |
|
Fax |
|
Email |
pushpalathania@gmail.com |
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Details of Contact Person Public Query
|
Name |
DrPratima |
Designation |
MS Scholar |
Affiliation |
National Institute of Ayurveda, Jaipur |
Address |
Department of prasuti tantra
National Institute of Ayurveda Madhav Villas Palace
Jorawar Singh Gate
Amer road
Jaipur 302002
Jaipur RAJASTHAN 302020 India |
Phone |
9669468199 |
Fax |
|
Email |
chotiprasad@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Ayurveda Jaipur |
|
Primary Sponsor
|
Name |
National institute of ayurveda |
Address |
Department of prasuti tantra
National Institute of Ayurveda Madhav Villas Palace
Jorawar Singh Gate
Amer road
Jaipur 302002
|
Type of Sponsor |
Research institution and hospital |
|
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 Pratima |
National institute of Ayurveda |
Department of prasuti tantra
National Institute of Ayurveda Madhav Villas Palace
Jorawar Singh Gate
Amer road
Jaipur 302002 Jaipur RAJASTHAN |
9669468199
chotiprasad@GMAIL.COM |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
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Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
GROUP A
Agnikarma with shalaka |
Agnikarma with Shalaka only for one sitting followed by Ghrita and Madhu in sufficient quantity will be applied over the wound once a day per week for one month.
Triphala Guggulu 500 mg BD for 15 days Orally
|
Intervention |
GROUP B
Virechana karma with Trivrit lehya
|
Virechana karma with Trivrit Lehya along with Jatyadi tail yoni pichu.Pichu size 2X4CM,soaked in 20 ML of Oil. Administration for twice in a week for one month after completion of the bleeding phase of menstrual cycle.
Triphala Guggulu 500 mg BD for 15 days after Virechana karma orally
|
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Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
1) Clinically diagnosed patients of cervical erosion (Karnini) by per speculum examination.
2) Patient willing to consenting undergo trial.
3) Married women irrespective of parity.
4) Age between 20 to 45 years
|
|
ExclusionCriteria |
Details |
1)Patient not consenting to the trial.
2)Pregnant women having cervical erosion.
3)Patients positive with Human Immunodeficiency Virus, VDRL and HBs Ag
4)Patients with Intra Uterine Contraceptive Device insertion or on Oral contraceptive pills.
5)Any organic pathology of reproductive tract like endometrial cancer, cervical cancer, cervical intraepithelial neoplasia.
6)Patient having severe systemic disorders like Diabetes, Hypertension, Tuberculosis etc.
7)Patients with Menorrhagia, Metrorrhagia and Polymenorrhoea.
8)Patient having second and third degree of uterus prolapse.
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in the cervical erosion on Colposcopic assessment . |
8 Week |
|
Secondary Outcome
|
Outcome |
TimePoints |
To relief in associated symptom like white discharge p/v, lowback pain etc.
|
8 Week |
|
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 |
Date of First Enrollment (India)
|
01/05/2020 |
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="6" 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)?
|
Brief Summary
|
Gynecological disorders are those disorders that affect
the female reproductive system. Cervical erosion is one of them. Normally
endocervix is covered by columnar epithelium and ectocervix is covered by
squamous epithelium, but in erosion, it is replaced by columnar epithelium.
Many of the times infection is the reason for change in epithelial covering.
But sometimes hormonal changes also play a pivotal role in the changes of
epithelial lining, patient suffers with offensive, irritant, profuse vaginal
discharge, formation of nabothian follicle, contact bleeding, dyspareunia,
intermenstrual bleeding, bowel irritating pelvic pain etc. If it is associated
with cervicitis that leads to low back pain. It is also a cause of infertility
and constitutional ill-health and sometimes it produces great psychological
upset in women. If it is left untreated, in the chronic stages the columnar
epithelium undergoes squamous metaplasia.
In Ayurveda classics almost all of the
gynecological disorders are described under the topic
of yonivyapad which are twenty in numbers.Karnini Yonivyapadis one
among them, seems to be near to Cervical erosion. . Its prevalence is more
than 50% of all the gynecological conditions
In the
present study two procedures are selected for comparison purpose in which first
is Agnikarma and second is Virechana karma. Acharya Charaka quoted that
there is a chance of recurrence in disease treated by shaman therapy but
Shodhan therapy cure the disease from its root and there is no chance of
recurrence. For that Virechana karma has been selected as a Panchkarma
procedure in present study.Virechana karma have been described in various
Samhitas for Yonidosha .and GranthiChikitsa. There
is need of study to rule out the effective, safer and economical methods
of Doshas shodhna for the management of cervical erosion.
30 patients suffering from karnini Yonivyapad (Cervical erosion) from OPD
& IPD National Institute of Ayurveda, Jaipur will be selected
according to the inclusion criteria , irrespective of religion,
occupation and socio-economic status. Patients will be randomly divided into
two groups. In group A Agnikarma with shalaka and group B Virechana
karma with Trivrit lehya.
Agnikarma
procedure - The patient is in lithotomy
position and the part is cleaned with aseptic solutions and draping done.
Speculum is to be introduced into the vagina and assessment of the cervical
erosion done. Then cervix is to be cleaned. There after
Agnikarma done by sterile pre heated shalaka instrument applied to the
eroded part of cervix.The sign of Samyaka Dagdha is the Kapota / Talaphalavata
and bluish brown colour will be marked.
Virechana
karma procedure - First of all Deepana ,Pachna with
Panchkola churna(3gm ) twice a day before food till apperances of Nirama
lakshana,snehapana with Go ghrita till samyaka snigdha lakshna.
than virechana karma will be induced by Trivrit lehya.
Virechana karma followed by Sansarjana karma per the type of shuddhi.
Colposcopy will be used as the objective parameter,
follow up will be done after 7 days of treatment which will be carried out for
1 month. Assessment will be done on the basis of objective and subjective
parameter before treatment, after treatment, and during last follow up.
Appropriate statistical test will be applied.
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