| CTRI Number |
CTRI/2024/06/069640 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying the effect of Navel filling with medicated oil in relieving symptoms of premenstrual syndrome |
|
Scientific Title of Study
|
An Exploratory Study to evaluate the effect of Nabhi Puran(Navel Oiling) with Erandmool Siddha Tail in PMS (Premenstrual Syndrome) in order to restore Normal Physiology |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Rajkumar Bhosale |
| Designation |
MD Scholar Kriya Sharir |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune 411018 |
| Address |
Department of Kriya Sharir
Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9545597509 |
| Fax |
|
| Email |
bhosale20priyanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita S Kadu |
| Designation |
Head of Department of Kriya Sharir |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir
Dr D Y Patil College of Ayurveda and Research Centre
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850684960 |
| Fax |
|
| Email |
mahismita326@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita S Kadu |
| Designation |
Head of Department of Kriya Sharir |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre Pimpri Pune |
| Address |
Department of Kriya Sharir
Dr D Y Patil College of Ayurveda and Research Centre
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850684960 |
| Fax |
|
| Email |
mahismita326@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Ayurveda and Research Centre, sant tukaram nagar, Pimpri Pune, Maharashtra, India 411018
|
|
|
Primary Sponsor
|
| Name |
Priyanka Rajkumar Bhosale |
| Address |
Dr D Y Patil College of Ayurveda and Research Centre,sant tukaram nagar, pimpri, pune, Maharashtra, India 411018
Sant Tukaram Nagar Pimpri Pune |
| 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 Priyanka Rajkumar Bhosale |
Dr D Y Patil College of Ayurveda and Research Centre Pimpri, Pune, Maharashtra, India 411018 |
Department or OPD of Swasthwritta and Kayachikitsa.
Dr. D.Y.Patil College of Ayurveda and Research Centre
Sant Tukaram Nagar, Pimpri, Pune,MAHARASHTRA
Pune
MAHARASHTRA |
9545597509
bhosale20priyanka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y.Patil college of Ayurved and Research Centre institutional Ethics 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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Erandmool siddha Tail, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 16(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 18 Days, anupAna/sahapAna: No, Additional Information: - As a single ingredient erandmool (roots) origin oil is not mentioned in classical text. but the Erandtail mentioned in classical text is of its seeds origin and not of root origin. but erandmool is used in oil formulations along with some other dravyas too. like amrutadya tail in vaat vyadhi chikita adhyay by Acharya Charaka and also mentioned in vidangadi tail along with some other ingredients by Acharya Char |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
The volunteers who duly signed the consent form will be considered
Volunteers will be considered who will fulfil diagnostic criteria of Premenstrual Syndrome Scale |
|
| ExclusionCriteria |
| Details |
The subject found other than inclusion criteria will be excluded
Subject taking any medication for any gynaecological problems like PCOS or uterine prolapse or pelvic floor prolapse or uterine fibroid |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
change in severity of symptoms
after use of Nabhi Puran |
0th day and 20th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any secondary effects or side effects after use of Nabhi Puran |
0th day and 20th day |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
08/07/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Menstrual history will be taken from volunteers like previous date of 1st day of menses and days of flow and number of pads used and symptoms according to PMSS Questionnaire. Volunteers in which 1 somatic and 1 behavioural symptom present for atleast 2 menstrual cycles in a row according to Premenstrual syndrome scale will be enrolled in study. Date of Ovulation day will be calculated . Erandmool Siddha Tail is to be given to volunteers to be used for Navel oiling from the day of ovulation to the 1st day of menses that is for 14 to 18 days. Procedure should be done by volunteers itself. It should be done empty stomach at evening or 2 hours after dinner before sleep. Volunteers will be asked to massage over stomach in clockwise direction in 200 rotations by taking 7 to 8 drops of luke warm erandmool siddha tail or oil in navel and rest in supine position for atleast 15 to 20 minutes. Any change in symptoms from day of ovulation to day of last menses is observed and recorded. |