| CTRI Number |
CTRI/2025/05/087488 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Anuvasan Vati and Yoni Picchu in Sukha Prasava |
|
Scientific Title of Study
|
A clinical study of Anuvasan Vati and Yoni Picchu in Sukha Prasava |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rinki Kumari |
| Designation |
Postgraduate Scholar |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Prasuti tantra avum stri rog Department
Budhamurti Kadamkuan Patna Bihar
Budhamurti, Kadamkuan, Patna, Bihar, 800003
Patna
BIHAR
800003
India |
| Phone |
7992355429 |
| Fax |
|
| Email |
rinkikumari16042017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Kumari |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Prasuti tantra avum stri rog Department
Government Ayurvedic College and Hospital, Budhamurti, Kadamkuan, Patna
Budhamurti, Kadamkuan, Patna, Bihar, 800003
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinki Kumari |
| Designation |
Postgraduate Scholar |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Prasuti tantra avum stri rog Department
Budhamurti Kadamkuan Patna Bihar
Budhamurti, Kadamkuan, Patna, Bihar, 800003
Patna
BIHAR
800003
India |
| Phone |
7992355429 |
| Fax |
|
| Email |
rinkikumari16042017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital |
| Address |
Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 India |
| Type of Sponsor |
Other [Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 India] |
|
|
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 Rinki Kumari |
Government Ayurvedic College and Hospital |
Prasuti tantra avum stri rog Department
OPD no 1
Government Ayurvedic College and Hospital Budhamurti Kadamkuan Patna Bihar 800003 India
Patna
BIHAR |
9835482491
rinkikumari16042017@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: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anuvasana Vasti and Yoni Picchu |
Anuvasana Vasti
Dose - 50 ml once in a week
Duration - one month
Yoni Picchu
Dose - 10 ml daily
Duration - one month |
| Intervention |
Anuvasana Vasti and Yoni Picchu |
Anuvasana Vasti
Dose- 50 ml twice in a week
Duration - one month
Yoni Picchu
Dose - 10 ml daily
Duration - one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Patient willing for trail
2 The Subject willing to cooperate in the study
3 Subject having age between 18 to 35 years both age included
4 Gestational age lies between 32-37 week preferences to primigravida
5 The subject free from chronic psychosomatic illness and its secondary complication |
|
| ExclusionCriteria |
| Details |
1 Patients with age group less than 18 years and greater than 37 years
2 Patients having contracted pelvis, malpresentation
3 Systemic Chronic illness like diabetes mellitus, tuberculosis, jaundice etc
4 Any sort of Eclampsia, Preeclampsia.
5 Any sort of Tachycardia, Bradycardia, Hypertension etc
6 Any type of mental disorder like epilepsy might be excluded from the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from sign and symptoms |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of effects of intervention w.r.t others |
30 days |
|
|
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)
|
14/06/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anuvasana Vasti by its superior therapeutic and rejuvenating action is best among all Panchakarma Procedure. Acharya Charaka called it as Ardha Chikitsa because of its instant effect with multidimensional action, utility in all types of diseases. Anuvasana Vasti is one of the types of Vasti have wide scope in day to day clinical practice as it can be adopted for every individual irrespective of their age and sex. Anuvasana vasti is half in quantity of Sneha Vasti. Anuvasana Vasti is main Vasti divided in to Sneha Vasti, Anuvasana Vasti and Matra Vasti; all three are combindly called as Anuvasana Vasti. Several research works have been carried out to observe efficacy of various Anuvasana Vasti in various disease condition but literary review with respect to dose, time, preparation of Vasti, retention time, Vasti Pratyagamana Kala along with standard protocol has not been much focused. so attempt has been made to elaborate facts of Anuvasana Vasti in clinical practice
Yoni Picchu is Ayurvedic therapy designed especially woman and for treating various gynaecological disorders. The treatment name is derived from the Sanskrit word Yoni meaning the genital part. Yoni Pichu (pichu means "cotton ball") is a treatment in Indian Ayurvedic medicine where a sterile cotton swab or cotton tampon, soaked in medicated oil (with often at least sesame oil) or ghee is kept inside the vagina for a specific period of time. It’s a treatment modality used to combat a variety of gynecological diseases and discomforts in females and it’s also applied in the pregnancy for Sukh Prasav.
The treatment involves procedures that cleanse the vaginal area using medicated oils. In the Ayurvedic treatment of Yoni Picchu, a sterile medicated cotton swab, dipped in medicated, Ayurvedic oil or ghee, is placed at post fornix of the vagina. The swab/roll of cloth should be retained for a specified period of time, as advised by the Ayurvedic physician. |