| CTRI Number |
CTRI/2020/02/023283 [Registered on: 13/02/2020] Trial Registered Prospectively |
| Last Modified On: |
12/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [comparison of unani formulation & dry cupping in primary dysmenorrhea] |
| Study Design |
Other |
|
Public Title of Study
|
Painful menses |
|
Scientific Title of Study
|
Effect of a Unani formulation & hijamah bila shurt in Primary dysmenorrhoea – A comparative open labelled observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Farha Naz |
| Designation |
PG Scholar |
| Affiliation |
National institute of unani medicine |
| Address |
Kottigepalya, magadi main road
Bangalore
KARNATAKA
560091
India |
| Phone |
7417627637 |
| Fax |
|
| Email |
farhanazamu4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ismath Shameem |
| Designation |
Reader |
| Affiliation |
National institute of unani medicine |
| Address |
kottigepalya, magadi main road
Bangalore
KARNATAKA
560091
India |
| Phone |
9538274583 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farha Naz |
| Designation |
PG Scholar |
| Affiliation |
National institute of unani medicine |
| Address |
kottigepalya, magadi main road
Kottigepalya, magadi main road
Bangalore
KARNATAKA
560091
India |
| Phone |
7417627637 |
| Fax |
|
| Email |
farhanazamu4@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of unani medicine. |
|
|
Primary Sponsor
|
| Name |
National institute of unani medicine |
| Address |
National institute of unani medicine,kottigepalya magadi main road,bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Farha Naz |
National instutute of unani medicine. |
kottigepalya, magadi main road
Bangalore
KARNATAKA |
7417627637
farhanazamu4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research |
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 |
| Comparator Agent |
Dry cupping |
3 medium size cup will be applied below the umblicus for 15 minutes per sitting on every alternate day.
1 sitting prior to menses and 2 sittings during menses |
| Intervention |
unani formulation in syrup form |
Oral administration of a Unani formulation. The ingredients are;
1-Majeeth (Rubia cordifolia Linn),
2-Tukhm-e-shibbat (Anethum sowa Linn),
3-Ajwain (Ptycotis ajowan Linn)
All ingredients are taken in a dose of 9 g each, cleaned, boiled and filtered; 270g of sugar will be added to prepare sharbat as per the method mentioned in Unani text. 15ml sharbat will be administered orally twice daily. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1-patients in age group of 15-35 yrs with regular menstrual cycle (21-35 days) having moderate to severe painful menses
2-VAS score of 4-10 and VMS of grade 2-3 and primary dysmenorrhoea accompanied with nausea, vomiting, dizziness, headache, diarrhea and tiredness. |
|
| ExclusionCriteria |
| Details |
1-secondary dysmenorrhoea
2-Organic pelvic pathology (Pelvic inflammatory disease, uterine fibroids, endometriosis, adenomyosis, adnexal masses, endometrial polyp)
3-H/o use of OCP’s or IUCD, abdominal & pelvic surgery
4-Systemic illness (Hypertension, & Diabetes mellitus), H/o urinary tract infection, Irritable bowel syndrome, Acid peptic disease, skin diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in menstrual pain |
Monthly for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS and VMS score |
Monthly for 3 months |
|
|
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)
|
10/02/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dysmenorrhea is the most common gynecological problem among females and it is defined as painful menses which occur in the absence of any identifiable pelvic pathology. It is the leading cause of absenteeism from school,work,and reduced physical quality of life. Pain is the subjective symptom There is wide spectrum of clinical presentation comprising of colicky suprapubic pain, lumbo sacral backache radiating to anterior thighs, nausea, vomiting, diarrhoea, giddiness and tiredness. Intensity of pain is described as mild,moderate & severe.The aim of the present study is to evaluate & compare the effect of a Unani formulation & dry cupping in patients with primary dysmenorrhoea. Necessary laboratory investigations will be done during the study period. Research drug will be given orally in sharbat form twice daily for 7 days/cycle for 3 consecutive cycles. Dry cupping will be applied below the umbilicus for 15 minutes/cycle on every alternate day during menses (total 3 sittings). Assessment will be done before & after period for 3 consecutive cycles during treatment & once in a month for 1 month after treatment. It is assumed that research drug & dry cupping may be useful to relief menstrual pain in patients with primary dysmenorrhoea. |