| CTRI Number |
CTRI/2023/03/050767 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial of Ashwagandha Ghrita in management of pre menstrual syndrome |
Scientific Title of Study
Modification(s)
|
A SINGLE ARM CLINICAL TRIAL OF ASHWAGANDHA GHRITA TO REDUCE THE SYMPTOMS OF PITTAVRITTA VYANA VAYU W.S.R. TO PREMENSTRUAL SYNDROME.. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Sanjay Lokhande |
| Designation |
PG scholar |
| Affiliation |
Yashwant ayurvedic College Kodoli |
| Address |
OPD no 8 striroga prasuti tantra OPD Yashwant Charitable Hospital Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7745003481 |
| Fax |
|
| Email |
snehallokhande58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Vishala |
| Designation |
Professor and HOD |
| Affiliation |
Yashwant ayurvedic College Kodoli |
| Address |
Second floor department of striroga prasutitantra Yashwant Charitable Hospital Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Sanjay Lokhande |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic College Kodoli |
| Address |
OPD no 8 striroga prasuti tantra OPD Yashwant Charitable Hospital Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7745003481 |
| Fax |
|
| Email |
snehallokhande58@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic College Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Sanjay Lokhande |
| Address |
OPD no 8 striroga prasuti tantra OPD Yashwant Charitable Hospital Kodoli |
| Type of Sponsor |
Other [Self] |
|
|
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 Snehal Sanjay Lokhande |
Yashwant Charitable Hospital Kodoli |
Yashwant Charitable Hospital Kodoli
Kolhapur
MAHARASHTRA |
7745003481
snehallokhande58@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:N943||Premenstrual tension syndrome. Ayurveda Condition: PITTAVRUTAVYANAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Ghrita , Reference: Bhavprakasha , Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1)diagnosed Patient based on signs and symptoms of Pitta avruta vyana vayu w.s.r. premenstrual symptoms.
2) Patients are selected of age group between 18-30 years.
3) Regular menstruating females and whose periodic cycle is regular 2-6 days
(25- 31 Day cycle)
4)Patient irrespective of marital status, obstetric status ,education , occupation.
5)Patient having BMI less than 30.
|
|
| ExclusionCriteria |
| Details |
1) K/H/O mood disturbance because of any systemic disorder / any other psychiatric disorders
2) Women with K/H/O severe systemic illnesses
3) Women who taking oral contraceptives and hormone replacement therapy
4) Premature ovarian failure.
5) Major gynaecological disorders.
6) Patient having BMI more than 30.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the symptoms of pittavritta vyana vayu W.S.R to premenstrual syndrome on assessment of subjective parameters like sarvang daha, klama, gatra vikshepa, sanga, santap, vedana. |
4 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To reduce the signs and symptoms
2)To assess improvement by parameters
3)To study etio pathology of pittavritta vyana vayu and premenstrual syndrome in details with classical ayurvedic and modern text
4) To achieve the outcome in 150 days |
150 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a single arm clinical study of ashwagandha ghrita in pittavritta vyana vayu W.S.R to premenstrual syndrome . Observations will be made upon symptoms of pittavritta vyana vayu W.S.R to premenstrual syndrome. Study will be carried in the OPD of striroga prasutitantra department of Yashwant ayurvedic College Kodoli. |