| CTRI Number |
CTRI/2021/01/030173 [Registered on: 01/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Vataja Yonivyapada (Gynecological disorders) with Rasnadi ksheerapaka and Sahacharadi Taila matra basti |
|
Scientific Title of Study
|
Management of Vataja Yonivyapada with oral Rasnadi ksheerapaka and Sahacharadi Taila matra basti. An open labelled randomised comparative phamaco-clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monisha V M |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty Of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9946859177 |
| Fax |
|
| Email |
dr.monishavm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty Of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranu369@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Roy |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra Faculty Of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956630433 |
| Fax |
|
| Email |
dranu369@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal Hospital IMS BHU |
|
|
Primary Sponsor
|
| Name |
Department of Prasuti Tantra |
| Address |
Department of Prasuti Tantra Faculty Of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department Of Pharmacology Institute of Medical Sciences Banaras Hindu University |
Department Of Pharmacology Institute of Medical Sciences Banaras Hindu University Varanasi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Roy |
Sir Sunderlal Hospital |
Prasuti Tantra OPD No 24 and IPD of Department Of Prasuti Tantra FOA Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
9956630433
dranu369@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, (2) ICD-10 Condition:N949||Unspecified condition associated with female genital organs and menstrual cycle. Ayurveda Condition: yonirogah, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rasnadi Ksheerapaka |
Rasnadi Ksheerapaka (48ml) oral will be given for 45 days early morning before taking food |
| Comparator Agent |
Sahacharadi Taila matra basti |
Sahacharadi Taila matra basti (72ml) will be given per rectum soon after the breakfast after clearance of menstruation for 8 days for 3 consecutive cycles |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient complaining of any 2 sympptoms of toda and vedana of yoni ( Pricking and other pain of vagina), stambha ( Stiffness), pipeelikasrupthim (Sensation as if creeping of ants ), karkasata ( Roughness ), supti ( Numbness) and ayasa ( Fatigue or lethargy) and also phenila (Frothy menstrual blood) , arunakrishna ( Reddish black menstrual blood), alpa (Oligomenorrhea), tanu ( Thin menstrual blood), ruksha artavasruti ( Menstruation appers dry), associated with vyadha of vankshana and parsva (Pain in groins and flanks ) for at least 2 consecutive cycles. |
|
| ExclusionCriteria |
| Details |
Pregnant women, women with chronic ailments (systemic diseases like TB, DM, jaundice, bronchial asthma, cardiovascular diseases, renal problems) piles, fistula, fissures or having any history of psychological disorders.Women who is suffering from svasa, kasa, hikka, alaska, visuchika, madhumeha, kushta, sleepada, galaganda.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Asseseement will be done on the basis of prepared proforma and improvement in sign and symptoms of vataja yonivyapada |
In first group 5 follow ups will be done at regular interval of 15 days. in second group treatment will be started in post menstrual period for 8 days for 3 consecutive cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in criteria listed in different scales. |
In first group 5 follow ups will be done at regular interval of 15 days. In second group treatment will be started in post menstrual period for 8 days for 3 consecutive cycles. 8 follow ups with regular interval of 15 days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/01/2021 |
| 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="2"
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
|
|
Brief Summary
|
Vataja yonivyapada is one among 20 yonivyapada (diseases related to pelvic organs). Women of vata prakriti when consumes diet
and indulges in other activities capable of aggravating vata reaching
reproductive system produces symptoms such as toda and vedana in yoni,
stambam, pipeelikasruptim, karkasata, supti and ayasa and also
phenila, arunakrishna, alpa, tanu, ruksha artava sruti associated with vyadha
of vamkshana and parsva and also other symptoms of vata dosha. For this purpose of present clinical study, oral Rasnadi Ksheerapaka (48ml) and Sahacharadi taila matra basti (72ml) per rectum are selected as a trial drugs for comprehensive clinical trial in vataja yonivyapada. There are 2 groups A and B designed. In group A Rasnadi Ksheerapaka 48ml oral in early morning before taking food for 45 days and in group B Sahacharadi taila matra basti 72ml per rectum after clearance of menses soon after the breakfast for 8 days for 3 consecutive cycles. Assessment will be done on the basis of prepared proforma for subjective and objective parameters including improvement in signs and symptoms of vataja yonivyapada . |