| CTRI Number |
CTRI/2024/11/077265 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Research on painful menstruation |
|
Scientific Title of Study
|
Efficacy of Joshanda Chiraita and sitz bath in Usr al Tamth Tashanuji Spasmodic Dysmenorrhea A Randomized Standard Controlled Study |
| 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 SARA MUJEER |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6 Department of Ilmul Qabalath wa Amraze
Niswan Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
Bangalore KARNATAKA 560079 India |
| Phone |
8147847886 |
| Fax |
|
| Email |
nazsarabia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aisha Anjum A |
| Designation |
Professor and HOD |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6 Department of Ilmul Qabalath wa Amraze
Niswan Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
Bangalore KARNATAKA 560079 India |
| Phone |
8951592300 |
| Fax |
|
| Email |
dr.aanjuma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Aisha Anjum A |
| Designation |
Professor and HOD |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Room no G6 Department of Ilmul Qabalath wa Amraze
Niswan Government Unani Medical College and Hospital
Basaweshwaranagar
Bangalore
Bangalore KARNATAKA 560079 India |
| Phone |
8951592300 |
| Fax |
|
| Email |
dr.aanjuma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Unani Medical College & Hospital Bangalore-560079
|
|
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Primary Sponsor
|
| Name |
Government Unani Medical College & Hospital Bangalore-560079 |
| Address |
Government Unani Medical College & Hospital Bangalore-560079 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SARA MUJEER |
Government Unani Medical College and Hospital |
Room no G6,
Department of Ilmul
Qabalat was Amraze
niswan,Dr Siddaiah
Puranik Road,
Basaveshwaranagar
Bangalore-560079
Bangalore
KARNATAKA Bangalore KARNATAKA |
8147847886
nazsarabia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) for Biomedical Research Government Unani Medical College Bangalore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aqueous Extract of Chiraita and Ābzan (Sitz bath) |
Aqueous extract will be prepared with coarsely powdered Chiraita by subjecting it to Maceration. The obtained aqueous extract containing the potent phytoconstituents will be further concentrated using water bath and dried. 500mg aqueous extract powder will be filled into capsules and administered orally in morning.
Ä€bzan (Sitz bath)
Decoction is prepared with 30gms of Chiraita. This decoction is added to a tub of luke warm water in which buttock and hips can be immersed. The procedure will be done for 15-20 minutes in the morning from D1–D3 of menses |
| Intervention |
JoshÄnda Chiraita (decoction) and Ä€bzan (Sitz bath) |
JoshÄnda (decoction) is prepared by boiling 5g of Chiraita, soaked overnight in 100ml of water, till it reduces to half of its volume(50ml) and administered orally after filtering, in the morning on empty stomach.
Ä€bzan (Sitz bath)
Decoction is prepared with 30gms of Chiraita. This decoction is added to a tub of luke warm water in which buttock and hips can be immersed. The procedure will be done for 15-20 minutes in the morning from D1–D3 of menses. |
| Comparator Agent |
Mefenamic acid 500mg |
Mefenamic acid 500mg will be given twice daily from D1-D3 of menses. |
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Both married and unmarried subjects between the age group of 12years to 35 years
Subjects with regular painful menstrual cycle 28±7day
Subjects with spasmodic dysmenorrhea having Visual Analogue Scale VAS Score for pain intensity more than 4
|
|
| ExclusionCriteria |
| Details |
Patients with systemic illness like hypertension, diabetes mellitus and thyroid dysfunction.
Patient with pelvic pathology like PID, uterine fibroids, endometriosis, adenomyosis.
Patient on any hormonal treatment
Lactating women
Patients allergic to NSAID’s
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| VAS score for pain intensity |
Every month after menstruation for 3 months
One follow up in subsequent cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SF-12 scale for QoL
Spasmodic dysmenorrhea associated symptoms
|
Every month after menstruation for 3 months
One follow up in subsequent cycle |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
30/11/2024 |
| 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="1" Months="0" 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
|
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Brief Summary
|
| Dysmenorrhea or painful menstruation is defined as a severe, painful, cramping sensation in the lower abdomen that is often accompanied by other symptoms, such as sweating, headache, nausea, vomiting and diarrhoea, that occur just before or during the menses. There are two commonly defined categories of dysmenorrhea: primary and secondary. Primary dysmenorrhea refers to pain during menses in the absence of any specific pathologic state and is characterized by recurrent, crampy, lower abdominal pain. Secondary dysmenorrhea refers to pain during menses that can be due to underlying pelvic pathology and is more common in women older than 20 years. Primary dysmenorrhea results from excessive production of prostaglandins at the time of ovulatory menses. In the second half of an ovulatory cycle, the withdrawal of progesterone from the normally involuting corpus luteum causes the release of phospholipids, in particular omega-6 fatty acids, which, in turn, are initially converted to arachidonic acid, and then to prostaglandins. This production of prostaglandin results in increased intrauterine pressure and abnormal uterine contractions. In addition, vasoconstriction of uterine vessels results in decreased blood flow, ischemia of the uterine muscles, and increased sensitivity of pain receptors, all of which cause pelvic pain. In Unani classical text, causes (Asbab) of dysmenorrhea is described as Sū’-i-MizÄj Mukhtalif of Rahim, RiyÄḥ al -ghaleez, Ruá¹Å«bat -i- Ghilẓ, Sudd’a-al-Rahim. Abnormal humour may cause pain either by their abnormal quality, quantity or combination of both factors. Various single drugs like chiraita, Abhal, Asarun, Sonf, Asgand, Amaltas, Annanas, Elva, Babuna, Bakain, Parshioshan, Podina, Khare khask, Hulba, Hilteet, Kalonji, Mushtar Mashi, Neem, Darchini, Qust Zanjabeel etc have been mentioned in classical Unani literature for the management of ‘Usr al- tamth . The visual analogue scale (VAS) is a robust and accurate assessment of the intensity of chronic pain. Because of its simplicity and reliability, VAS is a widely used validated scale with a 10 cm line (0-10 defined as no pain to worst pain). | Chiraita (Swertia chirata) also known as Qasabuzzarirah in Arabic language is a popular medicinal plant. It belongs to family Gentianaceae. According to Unani literature it possesses actions like Muá¹£affÄ«-i-Dam(blood purifying agent), DÄfi‘-i-ḤummÄ (antipyretic), Muḥallil-e-awram (anti-inflammatory), Mudirr-i-Bawl (diuretic) Mulaá¹á¹if (resolvent) KÄsir-i-RiyÄḥ (carminative) Mudirr-i-ḤayḠ(emmenogogue), MuqawwÄ«-i-Kabid (liver tonic), QÄtil-i-DÄ«dÄn-i-Am‘Ä’ (anti helminthic), mufriz-i- laban (galactogogue). |