| CTRI Number |
CTRI/2025/04/086042 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reducing the menstrual pain by herbal formulation |
|
Scientific Title of Study
|
An Exploratory Study to evaluate the effect of Chaturbeeja Arka in reducing the pain in Primary
Dysmenorrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepu Rani |
| Designation |
PG scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Amrita school of Ayurveda
AMRITA AYURVEDA HOSPITAL,Prasuti tantra and stir yoga department OPD department Room no. 8
clappana vallikavu kollam
kerala
Kollam
KERALA
690525
India |
| Phone |
9756900088 |
| Fax |
|
| Email |
deepu.rani23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.Hemavathi S.K |
| Designation |
HOD Prasuti tantra and stri roga d |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Amrita school of Ayurveda
clappana vallikavu kollam
kerala
Kollam
KERALA
690525
India |
| Phone |
9446962291 |
| Fax |
|
| Email |
hemavathi@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Deepu Rani |
| Designation |
PG scholar |
| Affiliation |
Amrita school of Ayurveda |
| Address |
Amrita school of Ayurveda
AMRITA AYURVEDA HOSPITAL,Prasuti tantra and stir roga,OPD No. 8
clappana vallikavu kollam
kerala
Kollam
KERALA
690525
India |
| Phone |
9756900088 |
| Fax |
|
| Email |
deepu.rani23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita ayurveda hospital
Amrita school of ayurveda,Prasuti tantra and stri roga department opd room no 8,clappana Kollam Kerala |
|
|
Primary Sponsor
|
| Name |
OTHER |
| Address |
Amrita school of ayurveda, Amrita ayurveda hospital,Prasuti tantra and stri roga department OPD NO.8
clappana vallikavu kollam kerala 690525 INDIA |
| Type of Sponsor |
Private medical college |
|
|
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 Deepu Rani |
Amrita Ayurveda Hospital,Amrita school of ayurveda |
Prasuti tantra and stri roga department opd room no 8
clappana vallikavu kollam Kerala 690525
Kollam
KERALA |
9756900088
deepu.rani23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita School of Ayurveda |
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: Chaturbeeja arka, Reference: ARKA PRAKASH BOOK by LANKAPATI RAVANA, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -Equal quantity of water), Additional Information: -IN book ARKA PRAKASH by LANKAPATI RAVANA in chaturth shatak shloka 12 there is direct reference of Chaturbeeja arka |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Regular menstrual cycles for three consecutive months having moderate to severe Primary Dysmenorrhea maintaining menstrual history diary or records.Those who have video calling facility on their mobile. |
|
| ExclusionCriteria |
| Details |
Participants with genitourinary infection, under hormonal therapy, diagnosed case of pelvic pathology, Plan for conception |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in intensity of pain using the vas scale. |
First three days of menstruation
for one menstrual cycle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in duration of pain and improvement in quality of life using CMSS and VMSS scale respectively |
first three days of menstruation cycle twice daily using video calls |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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="1"
Months="7"
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
|
Primary Dysmenorrhea is a most common disorder that affects upto 70% of the female population. It affects patients with significant impairment in quality of life, sleep,and work performance because of pain. The prevalence of Primary Dysmenorrhea has increased in recent decades due to sedentary lifestyle and unhealthy food habits. Primary Dysmenorrhea can be compared with Udavartini in Ayurveda,which is one of the diseases caused by vitiation of vata and can be treated with vata anulomana drugs. In the proposed research,a short term and more palatable drug approach will be used to treat primary dysmenorrhea. This study aims to assess the effectiveness of interventions with internally administered herbal formulations for better outcomes in the treatment of primary dysmenorrhea. The study is an exploratory study. A total of 40 patients fulfilling the inclusion criteria will be selected. The treatment protocol comprised Chaturbeeja arka 10 ml for first three days of menstruation twice orally with equal quantity of water for one menstruation cycle. Patients will be assessed based on Vas score,Cox menstrual symptom scale and VMSS scale. The data will be statistically evaluated with friedman test. |