CTRI Number |
CTRI/2023/07/055235 [Registered on: 14/07/2023] Trial Registered Prospectively |
Last Modified On: |
13/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Unani |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Efficacy evaluation of Unani formulation in pain during menstrual cycle. |
Scientific Title of Study
|
Efficacy and safety of Asaroon in primary dysmenorrhea in comparison with mefenamic acid: A randomized double blind standard controlled trial |
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 Hina Bano Nurullah |
Designation |
PG Scholar |
Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
Address |
Department of Ilmul Qabalat wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre 12 Naubagh Vijaypur Karnataka
Bijapur KARNATAKA 586101 India |
Phone |
7218871491 |
Fax |
|
Email |
drhinanurullah@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mohd Aqil Quadri |
Designation |
Professor |
Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
Address |
Department of Ilmul Qabalat Wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijaypur Karnataka
Bijapur KARNATAKA 586101 India |
Phone |
9849090182 |
Fax |
|
Email |
aqilquadri@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nikhat Kausar Inamdar |
Designation |
Assistant Professor |
Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
Address |
Department of Ilmul Qabalat Wa Amraze Niswan, Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijaypur Karnataka
Bijapur KARNATAKA 586101 India |
Phone |
7019276469 |
Fax |
|
Email |
nikhatinamdar72@gmail.com |
|
Source of Monetary or Material Support
|
Luqman Unani Medical College Hospital And Research Centre, 12, Naubagh, Bijapur, Karnataka, India, 586101 |
|
Primary Sponsor
|
Name |
Luqman Unani Medical College Hospital and Research Centre |
Address |
Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijaypur Karnataka |
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 Hina Bano Nurullah |
Luqman Unani Medical College Hospital and Research Centre |
PG-OPD No. 2, Ground Floor, Dept. of Ilmul Qabala wa Amraz-e-Niswan, Luqman Unani Medical College Hospital and Research Centre, 12 Naubagh, Bijapur, Karnataka-586101 Bijapur KARNATAKA |
7218871491
drhinanurullah@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, Luqman Unani Medical College Hospital & Research Centre |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Tablet Asaroon |
3 tablets of 500mg each, twice daily orally for 3 days in 2 consecutive menstrual cycles |
Comparator Agent |
Tablet Mefenamic acid |
1 tablet of 500mg twice daily orally for 3 days in 2 consecutive cycles. |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
35.00 Year(s) |
Gender |
Female |
Details |
Married and unmarried patients between 15 to 35 years of ages having regular menstrual cycles
Patient diagnosed with primary dysmenorrhea
Patients with Visual Analog Scale less than or equal to 4cm for at least three menstrual cycles before this study |
|
ExclusionCriteria |
Details |
Pelvic disease such as fibroid adenomyosis PID endometrial polyp ovarian tumour
Irregular menstrual cycles
Pregnancy and lactation
Systemic illness
Oral contraceptives and those Wearing IUCD devices
Participants with congenital anomalies of uterus |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Change in Severity of pain determined by VAS
Change in duration of menstrual pain |
before after treatment |
|
Secondary Outcome
|
Outcome |
TimePoints |
Change in HRQoL determined by SF-12 v1 health survey questionnaire
Change in PBLAC score for menstrual blood loss |
before after treatment |
|
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 2 |
Date of First Enrollment (India)
|
24/07/2023 |
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="1" |
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drhinanurullah@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
Dysmenorrhea (Difficult menstrual flow) is one of the most prevalent gynaecological problems that affects about half of all female adolescents or college-bound females, It interferes with their daily activities. One of the most frequent menstruation symptoms worldwide among people of reproductive age is dysmenorrhea, which is underdiagnosed and undertreated. It carries a worse illness burden than any other gynaecological condition in underdeveloped nations. Primary dysmenorrhea and secondary dysmenorrhea are the two main kinds of dysmenorrhea. Primary dysmenorrhea is described as menstrual cramping pain without any underlying pelvic pathology, and secondary dysmenorrhea is described as menstrual discomfort caused by any underlying pelvic disease. The most frequent justification for missing time at school, work, or family doctor appointments is dysmenorrhea ,and it occurs in ovulatory cycles, hence it makes its appearance a few years after menarche . It is still unclear how often primary dysmenorrhea actually is. However, Goerge and Bhaduri found dysmenorrhea to be a common problem in India with the prevalence of 87.7%. According to the WHO Data, as many as 94% of young girls aged 10-20 and 8.8% of woman aged 19-41 suffer from menstrual pain Primary dysmenorrhea can be treated with a range of pharmaceutical and non-pharmacological techniques, such as non-steroidal anti-inflammatory medications (NSAIDs) and oral contraceptives. The effectiveness of oral contraceptives and NSAIDs is considerable, however failure rates might still range from 20% to 25%. However analgesic are not an effective solution because of the risks for decreased effectiveness and increasing dependency . Some women with primary dysmenorrhea may not tolerate or be contraindicated for this therapy. Although there are treatments for menstruation pain, getting full relief is still challenging. Therefore, a low-toxic alternative herbal treatment is necessary . Terms used for dysmenorrhea in the Unani literature are dard-i-rahim , waja’al-rahim, or auja al-rahim and usr-i-tamth and to treat this condition, several drugs have been mentioned for oral as well as local application like birinjasif, kharnub, bazrulbanj, zarawand, mur, irsa, habbulgaar, pudina, jawitri,tukhme karafs ,rewand khatae, amaltas .Asaroon (Asarum europaeum L.), is one of them which can be given orally to relief dard al-rahim Numerous studies have shown that the extract of plants in the genus Asarum contains a rich complex of biologically active substances, including alkaloids, flavonoids, triterpene saponins, steroids, phlobatanin, amino acids, coumarins, higher fatty acids, polysaccharides, vitamins of group B, C, and E, essential oils, and others. Asarum (asaaroon) is currently scientifically and pharmacologically proven for its anti-inflammatory activity in animal models and are therefore can be helpful in reduction of menstrual pain Considering this fact, it has been decided to conduct the clinical trial to evaluate the efficacy of Asaroon in patients with primary dysmenorrhoea in comparison with mefenamic acid. |