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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  
 
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 Ä€bzan (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  Joshānda Chiraita (decoction) and Ä€bzan (Sitz bath)  Joshānda (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. 
 
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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
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
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-Mizāj Mukhtalif of Rahim, Riyāḥ 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),  Dāfi‘-i-Ḥummā  (antipyretic),  Muḥallil-e-awram (anti-inflammatory),  Mudirr-i-Bawl  (diuretic)  Mulaá¹­á¹­if  (resolvent)  Kāsir-i-Riyāḥ   (carminative)  Mudirr-i-Ḥayḍ (emmenogogue),  MuqawwÄ«-i-Kabid  (liver tonic), Qātil-i-DÄ«dān-i-Am‘ā’ (anti helminthic), mufriz-i- laban (galactogogue). 
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