| CTRI Number |
CTRI/2025/01/079255 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Cupping and Plantain Seeds versus Tranexamic Acid in Women in women with Heavy Menstrual Bleeding. |
|
Scientific Title of Study
|
Efficacy of Hijama Bila Shart and Tukhm Bartang versus Tranexamic Acid in Women with Kathrat-i-Hayd. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramsha Arshad |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Dept. of Amraze Niswan Kottigepalya, Magadi Main Road
Bangalore KARNATAKA 560091 India |
| Phone |
9109645156 |
| Fax |
|
| Email |
ramshaarshad21@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ramsha Arshad |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Dept. of Amraze Niswan Kottigepalya, Magadi Main Road
KARNATAKA 560091 India |
| Phone |
9109645156 |
| Fax |
|
| Email |
ramshaarshad21@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PROF DR ARSHIYA SULTANA |
| Designation |
Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Room No. 29, OPD, Dept. of Amraze Niswan Kottigepalya, Magadi Main Road,Bengaluru-560091, Karnataka
Bangalore KARNATAKA 560091 India |
| Phone |
09740915911 |
| Fax |
|
| Email |
drarshiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Kottigepalya, Magadi Main Road,Bengaluru-560091, Karnataka |
| Type of Sponsor |
Government 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 |
| Prof Dr Arshiya Sultana |
National Institute of Unani Medicine |
Room No. 29, OPD, Dept. of Amraze Niswan, Kottigepalya, Magadi Main Road Bangalore KARNATAKA |
9740915911
drarshiya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Unani Medicine, Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tranexamic Acid |
Tranexamic Acid 500 mg TID for 5 days from first day of menstruation |
| Intervention |
Tukhm Bartang (Plantago major L.) and Hijama bila Shart |
Tukhm Bartang will be given orally 5g will be given in three divided doses for 5 days from first day of menstruation. 2 large cups will be used below the breast for 15 minutes for 3 days from first day of menstruation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
Study participants in the age group of 18-42 years with regular cycles (21-35 days) with MBL greater than 80 ml or DOB greater than 7 days for 2 out of 3 consecutive cycles. Study participants with PBAC scores greater than 80ml and Samanta scores more than 3. Study participants with thickened endometrium up to 18 mm, adenomyosis,uterine fibroids less than 3 in number and less than 3 cm in size. Study participants with mild (Hb levels 11-11.9g/dL) to moderate (Hb levels 8 to 10.9.9g/dL) anemia.
|
|
| ExclusionCriteria |
| Details |
Study participants with co-morbidities such as uncontrolled hypertension (Stage 2 hypertension more than 140/90 mmHg), uncontrolled diabetes mellitus (FBS more than 130mg/dl or PPBS more than 180mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00%), uncontrolled hypothyroid, Bleeding disorders, severe anaemia (Hb less than 8gm%) and malignancy. Hormonal contraceptives in last 3 months. Study participants with uterine fibroid more than 3 in number and more than 3 cm in size.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PBLAC (Pictorial Blood Loss Assessment Chart) |
PBLAC (Pictorial Blood Loss Assessment Chart) will be assessed at baseline, week 4, 8, 12 and week 16 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Samanta questionnaire, MIQ (Menorrhagia Impact Questionnaire), Haemoglobin percentage |
The secondary outcome Samanta & MIQ will assessed after menstruation at baseline, week 4, week 8, 12 & week 16. Haemoglobin percentage will be assessed at baseline & week 12. |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
03/02/2025 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Heavy menstrual bleeding
(HMB) is diagnosed as excessive or prolonged uterine bleeding per menstruation
of more than 80 ml or for 7 days in a normal cycle. According to the traditional Unani texts, excessive
menstrual blood loss (MBL) with regular cycles and excessive bleeding, either
in volume or length, are the characteristics of heavy menstrual bleeding (HMB).
An alternative semiquantitative technique for
evaluating MBL makes use of a pictorial blood loss assessment chart (PBLAC). Menorrhagia can be effectively
treated using a variety of herbs and regimental therapy, such as dry cupping,
which is part of the Unani medical system. Plantago major, commonly known as great plantain or Tukhm
Bartang in Unani medicine, belongs to the Plantaginaceae family. Tukhm Bartang has
been chosen as a study drug among the various medications accessible for HMB.
It possesses Syptic, detergent, Musakkin,
and others. It contains several active compounds, i.e. phenolic
acids, flavonoids, tannins, polysaccharides, terpenoids, lipids, iridoid
glycosides, and caffeic acid derivatives. Application of dry cupping below the
breast is also useful to control heavy menstrual bleeding. The hypothesis of
the study will be dry cupping and Tukhm Bartang versus tranexamic acid in HMB will be
effective at post-intervention. The objective of the study is to determine
and compare the efficacy of dry
cupping and Tukhm Bartang versus tranexamic acid in HMB. Diagnosed cases of HMB fulfilling
the inclusion criteria will be randomly selected. Written informed consent will
be obtained from patients. The drug will be given either to the test or control
group. In the test group, 5g of Tukhm Bartang will be given in three divided
doses for five days and dry cupping for 3 days from the first day of menstruation
for 3 consecutive months. Patient global assessment of tolerability to therapy
will be assessed for safety and tolerability to therapy at the end of the
treatment. PBLAC, and Samanta
questionnaire will be assessed at baseline and each follow-up. MIQ (Menorrhagia
Impact Questionnaire) and Haemoglobin percentage will be assessed at baseline
and at the end of the intervention. The total sample will be 62 patients (31 in each group). The Primary
outcome will be assesd PBLAC (Pictorial Blood Loss Assessment
Chart). The secondary outcome will be Samanta
questionnaire, MIQ (Menorrhagia Impact Questionnaire), and Haemoglobin
percentage. The appropriate tests will be applied to analyse the
data. Descriptive statistical analysis will be used in the study. Results on
continuous measurements will be presented in mean (SD) and results on the
categorical measurements will be presented in number (percentage) with a 5 percent level of
significance and 95 percent confidence interval. |