| CTRI Number |
CTRI/2020/05/025422 [Registered on: 28/05/2020] Trial Registered Prospectively |
| Last Modified On: |
13/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on the role of Ayurvedic regimen in prasuta |
|
Scientific Title of Study
|
A clinical study on the role of charakokta regimen in sutika paricharya ; proof of concept study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Gurjar |
| Designation |
PG Scholar |
| Affiliation |
national institute of ayurveda jaipur |
| Address |
Department of prasuti and stri roga national institute of ayurveda jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
8952993305 |
| Fax |
|
| Email |
gurjarkomal427@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr B Pushpalatha |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of prasuti and stri roga national institute of ayurveda jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9413206790 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr B Pushpalatha |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of prasuti and stri roga national institute of ayurveda jaipur
Jaipur RAJASTHAN 302002 India |
| Phone |
9413206790 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Near Jorawar singh gate amer road jaipur Pin Code 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jorawar singh gate amer road jaipur |
| Address |
National Institute of Ayurveda Near Jorawar singh gate amer road jaipur 302002 rajasthan |
| 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 Komal Gurjar |
National Institute of Ayurveda |
Deptartment of Prasuti tantra avum stri roga national Institute of Ayurveda Near jorawar Singh gate amer road jaipur
Pin Code 302002 Jaipur RAJASTHAN |
8952993305
gurjarkomal427@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O909||Complication of the puerperium, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Pippalyadi Churna (Pippali,Pippalimoola,Chavya ,Sudha Chitrak , Nagar)(
2. Tila taila
3. Goghrita
4. Vidarikanda churna
|
1 Dose of Pippalyadi churna : 3 gm
2 Dose of tila taila : 30 ml
3 Dose of Goghrita : 20ml
4. Dose of vidarikanda churna : 4gm
5 Route of Churna : oral
6 route of tila taila : local application |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primipara/multipara with noncomplicated full term vaginal delivery,
2. Age between 20 – 35 years
3. Patient willing and able to participate in the study.
4. Women delivered with Muladhar chedan (episiotomy)
5. Women delivered with Muladhar bhedan (perineal tear)
|
|
| ExclusionCriteria |
| Details |
1. Woman who delivered by Caesarian section or forceps delivery/ vacuum application
2. Puerperium associated with complications like severe postpartum haemorrhage, acute inversion of uterus, puerperal eclampsia, psychosis, postnatal diabetes.
3. Women with evidence of malignancy.
4. Women having any systemic disorder.
5. Women having any infection during pregnancy.
6. Women on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of charakokta sutika paricharya in well being of sutika |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide more effective, safe and side-effect free management of Sutika . |
15days |
|
|
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)
|
01/06/2020 |
| 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="0" Months="0" Days="15" |
|
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
|
A
postnatal period begins immediately after the separation of placenta and
extending up to six weeks (this period varies as some Acharyas described up to 45days or up to 6 months after delivery)[1],otherwise
called as puerperium or puerperal period. The care given during this period is
called as Sutika Paricharya in Ayurveda. During the time of labour
mother undergoes tremendous physical exertion and becomes extremely debilitated
physically and mentally; which leads to derangement of Doshas especially Vata dosha
in the mother. These pathological changes cause general weakness, pain abdomen,
low back pain, loss of appetite, dysfunction of bladder, post-natal psychosis
etc. Apart from these, mother also suffers with Dhatukshya. If this stage is unattended by appropriate measures
then that will lead to maternal morbidity.
In order to reduce the postpartum
maternal morbidity, reforming postpartum care measures by providing holistic
and flexible maternal health care is necessary. The WHO suggested that maternal
care should be de-medicalized, individualized, family-centered, multidisciplinary,
holistic, and culturally appropriated.
In the existing modern medical system,
puerperal care limits to supplementation of the iron, calcium and prevention of
infections. Two major demands of Puerperium i.e. care for proper involution of
genital organs and ensuring optimum lactation are still left un-addressed.
Whereas in Ayurveda medicaments and
procedures described for post-natal woman is culturally very much appropriate,
is by and large comprehensive in serving all the demands of the pueperium. It
is by far more scientific and helps in proper involution of the uterus, ensures
optimum lactation, kindles digestive as well as metabolic fire, replenishes the
lost Dhatu (tissue elements),
prevents infections, helps to regain tone of urinary bladder and other smooth
muscle organs like intestine,finally it ensures the uneventfull pueperium and
complete growth of the body
|