| CTRI Number |
CTRI/2021/08/035334 [Registered on: 02/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of Rajapravartani Vati in Painful Menstruation |
|
Scientific Title of Study
|
A prospective community based study for the evaluation of Rajapravartani Vati in the Management of Primary Dysmenorrhoea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
CHRIS ANTONY |
| Designation |
Research Officer Ayurveda |
| Affiliation |
Regional Ayurveda Research Institute CCRAS Mandi Himachal Pradesh |
| Address |
Room No 4
Ayurveda Department
Kaumarabhritya Division
Regional Ayurveda Research Institute
Jaral Colony
Pandoh
Mandi District
Himachal Pradesh
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
7807773464 |
| Fax |
|
| Email |
chrisantony1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
CHRIS ANTONY |
| Designation |
Research Officer Ayurveda |
| Affiliation |
Regional Ayurveda Research Institute CCRAS Mandi Himachal Pradesh |
| Address |
Room No 4
Ayurveda Department
Kaumarabhritya Division
Regional Ayurveda Research Institute
Jaral Colony
Pandoh
Mandi District
Himachal Pradesh
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
7807773464 |
| Fax |
|
| Email |
chrisantony1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CHRIS ANTONY |
| Designation |
Research Officer Ayurveda |
| Affiliation |
Regional Ayurveda Research Institute CCRAS Mandi Himachal Pradesh |
| Address |
Room No 4
Ayurveda Department
Kaumarabhritya Division
Regional Ayurveda Research Institute
Jaral Colony
Pandoh
Mandi District
Himachal Pradesh
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
7807773464 |
| Fax |
|
| Email |
chrisantony1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences CCRAS New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan
61-65 Institutional Area
Opposite D Block Janakpuri
New Delhi 110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Susmita P Otta |
Central Ayurveda Research Institute Bhubaneswar |
Room No 02
Ayurveda Department
Prasuti evam Streeroga Division
Central Ayurveda Research Institute Bhubaneswar
Bharatpur
Bhubaneswar
Khordha
ORISSA |
8089375057
drsusmitaro@gmail.com |
| Dr Jeuti Rani Das |
Central Ayurveda Research Institute Guwahati |
Room No 209
Ayurveda Department
Rogavijnana Vikriti Vijana Division
Central Ayurveda Research Institute
Barsojai
Beltola
Guwahati
Kamrup District
Assam
PIN 781028
Kamrup
ASSAM |
9509192744
djeutirani@yahoo.in |
| Dr Rinku Tomar |
Central Ayurveda Research Institute Patiala |
Room No 211
Ayurveda Department
Prasooti evam Striroga Division
Central Ayurveda Research Institute Patiala
Moti Bagh Road Patiala
Punjab
Patiala
PUNJAB |
9888685874
drrinkutomer2008@gmail.com |
| Dr Swati Sharma |
M S Regional Ayurveda Research Institute Jaipur |
Room No 01
Ayurveda Department
Kaumarabhritya Division
M S Regional Ayurveda Research Institute Jaipur
Indira Colony
Banipark
Jhotwara Road
Jaipur
Jaipur
RAJASTHAN |
7318324555
drswatisharma2010@gmail.com |
| Dr Jaiprakash Ram |
Regional Ayurveda Research Institute Ahmedabad |
Room No 02
Ayurveda Department
Kayachikitsa Division
Regional Ayurveda Research Institute
Asarwa
Ahmedabad
Gujarat
PIN 380004
Ahmadabad
GUJARAT |
7791834211
jpram236@gmail.com |
| Dr Harit Kumari |
Regional Ayurveda Research Institute Lucknow |
Room No 312
Ayurveda Department
Shalyatantra Division
Regional Ayurveda Research Institute
INS 106
Sector 25
Indira Nagar
Lucknow
UP
PIN 226016
Lucknow
UTTAR PRADESH |
9837078947
drharit79@gmail.com |
| Dr Chris Antony |
Regional Ayurveda Research Institute Mandi |
Room No 4
Ayurveda Department
Kaumarabhritya Division
Regional Ayurveda Research Institute
Jaral Colony
Pandoh
Mandi District
Himachal Pradesh
Mandi
HIMACHAL PRADESH |
7807773464
chrisantony1@gmail.com |
| Dr Prashant R Shinde |
Regional Ayurveda Research Institute Nagpur |
Room No 02
Ayurveda Department
Prasutitantra evam Striroga Division
Regional Ayurveda Research Institute Nagpur
Near Gharkul Parisar
N I T Complex
Nandavan
Nagpur
Nagpur
MAHARASHTRA |
9623011214
drshindeprashant07@gmail.com |
| Dr Kuldeep |
Regional Ayurveda Research Institute Patna |
Room No 09
Ayurveda Department
Panchakarma Division
Regional Ayurveda Research Institute Patna
Agam Kuan
Patna
Patna
BIHAR |
8954354560
kuldeepccras@gmail.com |
| Dr Meghna P P |
Regional Ayurveda Research Institute Thiruvananthapuram |
Room No 21 First floor
Ayurveda Department
Prasutitantra Streeroga Division
Regional Ayurveda Research Institute Thiruvananthapuram
Poojappura
Thiruvananthapuram
Thiruvananthapuram
KERALA |
9074126423
drmeghnapp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics Committee RARI Nagpur |
Approved |
| Institutional Ethics Committee Central Ayurveda Research Institute Bhubaneswar |
Approved |
| Institutional Ethics Committee Central Ayurveda Research Institute Guwahati Assam |
Approved |
| Institutional Ethics Committee Central Ayurveda Research Institute Patiala |
Approved |
| Institutional Ethics Committee for Biomedical Research RARI Thiruvananthapuram |
Approved |
| Institutional Ethics Committee M S Regional Ayurveda Research Institute Jaipur |
Approved |
| Institutional Ethics Committee Regional Ayurveda Research Institute Ahmedabad Gujarat |
Approved |
| Institutional Ethics Committee Regional Ayurveda Research Institute Lucknow Uttar Pradesh |
Approved |
| Institutional Ethics Committee Regional Ayurveda Research Institute Mandi Himachal Pradesh |
Approved |
| Institutional Ethics Committee Regional Ayurveda Research Institute Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajapravartani Vati, Reference: AFI Part 1 12 25, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: Drug will be given for 3 menstrual cycles and follow up without drug will be done for 1 menstrual cycle |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
i.Young women of age 18 -25 years of scheduled Caste community
ii.Self-reported history consistent with primary dysmenorrheal of moderate to severe nature (Mild: doesn’t interfere in normal activities, Moderate: slightly interferes in daily routines but can be managed by painkillers, Severe: markedly prevents daily life activities) with a self-reported menstrual cycle of averaging 21-35 days.
iii.Willing and able to participate in the study (Written informed consent or assent).
|
|
| ExclusionCriteria |
| Details |
i.Irregular Cycles.
ii.Cases of secondary Dysmenorrhea
iii.Pain abdomen associated with excessive bleeding per vagina.
iv.Presence of persistent pelvic pain throughout the menstrual cycle.
v.Known case / diagnosis /h/o of leiomyoma of uterus, ovarian cyst, endometriosis.
vi.Associated with clinically diagnosed pelvic inflammatory disease (PID),
vii.Associated with any pre-diagnosed or clinically diagnosed systemic disorders likely to influence menstrual cycle.
viii.Patients with Hb ≤ 7 gm %
ix.History of malignancy of pelvic organs.
x.Diagnosed cases Hypo/hyperthyroidism .
xi.Woman using IUD / Oral Contraceptive Pills (OCP)
xii.Patient co morbid with systemic diseases like diabetes mellitus, hypertension, cardiac/ Renal/ Pulmonary/ Hepatic disorders.
xiii.Women who are planning to conceive in the next 6 months.
xiv.Participation in other concomitant therapy for acute or chronic pain.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i.Change in Visual Analog Scale (VAS) for pain. |
At baseline, after 1 month, after 2 months, after 3 months and after 4 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i.Changes in total WaLLID score.
ii.Change in Hb status of the subject from the baseline to the end of trial -12 weeks.
iii.Decrease in the use of Analgesic medication (dosage & frequency of medication used)
|
[Time Frame: Assessed via questionnaire after every menstrual cycle for four cycles] |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
04/08/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective community based study for the evaluation of clinical effects of Rajapravartani vati in the management of Primary Dysmenorrhoea. It is a single arm trial with a sample size of 50 at each partcipating center (total 10 CCRAS centers). The outcome measures are VAS Score and WaLLIDD score. |