| CTRI Number |
CTRI/2024/02/062406 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Chaturbeeja choorna in the management of primary dysmenorrhoea i.e., painful menstruation. |
|
Scientific Title of Study
|
An open label single arm clinical study on the effect of Chaturbeeja choorna in the management of Udavartini Yonivyapath vis-Ã -vis 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 |
Dr Anushree A B C |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
JSS Ayurveda Medical College and Hospital, Lalithadripura Road, Mysuru - 570028
Mysore KARNATAKA 570028 India |
| Phone |
8762023925 |
| Fax |
|
| Email |
anushreesagar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nanda K O |
| Designation |
Assistant Professor |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department Of PG Studies in Prasooti Tantra And Stree Roga, JSS Ayurveda Medical College And Hospital, Lalithadripura Road, Alanahalli, Mysuru
Mysore KARNATAKA 570028 India |
| Phone |
8970322532 |
| Fax |
|
| Email |
nandadeepak.dr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nanda K O |
| Designation |
Assistant Professor |
| Affiliation |
JSS Ayurveda Medical College And Hospital |
| Address |
Department Of PG Studies in Prasooti Tantra And Stree Roga, JSS Ayurveda Medical College And Hospital, Lalithadripura Road, Alanahalli, Mysuru
Mysore KARNATAKA 570028 India |
| Phone |
8970322532 |
| Fax |
|
| Email |
nandadeepak.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Anushree A B C |
| Address |
Department of PG Studies in Prasooti Tantra and Stree Roga, JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanhalli, Mysuru. |
| 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 Anushree A B C |
JSS Ayurveda Medical College and Hospital |
Department of PG Studies in Prasooti Tantra and Stree Roga, OPD no 9 Mysore KARNATAKA |
8762023925
anushreesagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chaturbeeja churna, Reference: bhavaprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -sukoshnajala), Additional Information: -5 days prior cycle and during cycle for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Female |
| Details |
Patients with regular cycles complaining of painful menstruation for at least 3 consecutive cycles. |
|
| ExclusionCriteria |
| Details |
Pelvic pathology - known case of fibroid, adenomyosis, endometriosis, pelvic inflammatory disease, menorrhagia, malignancy.
Patients with intrauterine contraceptive devices or on contraceptive pills
Congenital anomalies of reproductive systems
Metabolic disorders - known case of diabetes mellites, hypertension, thyroid dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the effect of Chaturbeeja choorna in the management of Primary Dysmenorrhoea. |
3 consecutive cycles follow up will be done on each cycle the assessment of any improvement in objective and subjective parameters will be assessed . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of drug on over all development & improvement pertaining general condition & haemoglobin levels will be assessed |
3 consecutive cycles follow up will be done on each cycle the assessment of any improvement in objective & subjective parameters will be assessed . |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2024 |
| 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="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
ü Dysmenorrhea is the most common
gynecological problem faced by women during their reproductive period which
causes significant discomfort and anxiety for the women as well as her family.
ü A systemic review of studies from
India reported the prevalence range between 50-87.8% in developing countries
performed by Agarwal & Agarwal (2010) have revealed that about 25-50% of
adult women and about 75% of adolescents experience pain during menstruation,
with 5-20% reporting severe dysmenorrhea or pain that prevent them from ensuing
day-to-day activities.1
ü In Udavartini Yonivyapath vitiation of Apana Vata is considered as primary cause as there’ll be Urdvagamana of Vata therefore the line of treatment is to ensure Vatanulomana and Vatahara action. So the
easily available and cost effective drug Chaturbeeja Choorna is chosen due to its Vatanulomana and Vatahara
action, therefore Udavartini Yonivyapath
management is achieved.2,3
ü In modern system NSAID are
often prescribed in the treatment of dysmenorrhea. During menstruation, many
women experience gastrointestinal discomforts which are increased by analgesics
and anti-inflammatory drugs, which also produce headache, dizziness, drowsiness
and blurred vision.
The role of hormones (estrogens-progesterone or contraceptive
pills) as a
prolonged therapeutic measure especially on unmarried girls for dysmenorrhea is
itself debatable. So there is a great scope of research to find out management
which is effective, to treat the entire feature complex with single regimen and
find out the treatment for the underlying pathology from Ayurveda for the
management of Udavartini Yonivyapath.
|