| CTRI Number |
CTRI/2025/12/098749 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Therapeutic ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research on Painful Menses in Unani Medicine |
|
Scientific Title of Study
|
Efficacy of Joshanda Baboona and its 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. Summaiya Mulla |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College And Hospital |
| Address |
Room no.11,Government Unani Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
7090250837 |
| Fax |
|
| Email |
drsummaiyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Manjula S |
| Designation |
Principal |
| Affiliation |
Government Unani Medical College And Hospital |
| Address |
Room no.11,Government Unani Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
9731628373 |
| Fax |
|
| Email |
drmanjulaprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Manjula S |
| Designation |
Principal |
| Affiliation |
Government Unani Medical College And Hospital |
| Address |
Room no.11,Government Unani Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
9731628373 |
| Fax |
|
| Email |
drmanjulaprasad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Unani Medical College and Hospital Bangalore 560079 |
|
|
Primary Sponsor
|
| Name |
Government Unani Medical College and Hospital |
| Address |
Government Unani Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore |
| 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 |
| Dr Summaiya Mulla |
Opd 11 Govt Unani Medical College and Hospital |
Room no.11,Government Unani Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwaranagar Bangalore
Bangalore
KARNATAKA |
7090250837
drsummaiyam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research Government Unani Medical College and Hospital |
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 |
Oral Administration of Joshanda Baboona with Local administration of Abzan(Sitz bath) |
Oral Administration,Joshanda (Decoction) will be prepared by boiling 7g of Baboona soaked overnight in 100ml of water till it reduces to half of its volume (50ml) and administered orally in two divided doses after filtering it from Day 1 to Day 3 of menses for 3 consecutive menstrual cycles.
Local Administration Abzan,
Joshanda (Decoction) will be prepared from 30 g of Baboona in 1 litre of water till it reduces to 500ml, then it is mixed with 4 litre of sterilized water added to a tub in which buttock and hips can be immersed. The procedure will be done for 20mins daily once from Day 1 to Day 3 of menses. |
| Comparator Agent |
Tablet Mefenamic acid 500mg orally |
Tablet. Mefenamic acid 500mg orally will be given twice daily from Day 1 to Day 3 of menses for 3 consecutive cycles |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Both unmarried and married participants with age group of 12 to 35years.
2.Participants with regular painful menstruation associated with one or more symptoms like lower backache,nausea,vomiting,diarrhea and fatigue.
3.Visual Analogue Scale VAS score for pain intensity more than 4. |
|
| ExclusionCriteria |
| Details |
1.Hb percent less than 7gms percent will be excluded.
2.Participants with systemic illness like hypertension,diabetes mellitus,thyroid
dysfunction.
3.Participants with pelvic pathology like pelvic inflammatory disease,uterine fibroid,
endometriosis,adenomyosis
4.Participants allergic to NSAIDs.
5.Participants on any hormonal treatment.
6.Lactating women within 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in VAS score |
Before, every month for 3 months during the trial and one follow up in subsequent cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in SF 12 scale for QoL
2.Change in Verbal Multidimensional Scoring scale |
1.Change in SF 12 scale for QoL Before & after trial
2.Change in Verbal Multidimensional Scoring scale Before, during & After trial |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
20/12/2025 |
| 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="6"
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
|
Usr al Tamth Dysmenorrhea means difficult menstruation but the term is commonly used to refer to painful menstruation. Many women with dysmenorrhea experience additional menstrual related symptoms such as backache ,headache diarrhea, nausea and vomiting. The first 24 to 48 hours after the start of menstrual flow, or within a few hours before or after, are usually characterized by these symptoms. Dysmenorrhea affects 16.8percent to 81percent of women, according to the WHO, with prevalence estimates among women and adolescents ranging from 25 percent to 90 percent Studies from India have shown prevalence rates ranging from 50 percent to 87.8 percent It affects more than half of females aged 18 to 25 years old. Dysmenorrhea is classified into two types: Primary dysmenorrhea, which describes cyclic menstrual pain without an identifiable associated pathology and Secondary dysmenorrhea, which frequently complicates conditions such as endometriosis, leiomyomas, PID, adenomyosis, endometrial polyps and menstrual outlet obstruction. In conventional medicine, the treatment of choice for this problem generally includes NSAIDs, hormonal preparations like OCPs and surgery. However, these methods have also been found to have a failure rate of 20-25 percent. Additionally, these drugs can aggravate gastrointestinal problems and lead to adverse drug interactions.
Unani physicians have discussed dysmenorrhea and its management under the heading of Waja al Rahim, Dard al Rahim. Various single drugs such as Zanjabeel Zingiber officinale Roscoe. Saunf Foeniculum vulgare Mill, Zafran Crocus sativus L., Zeera Siyah Cuminum cyminum Linn. Baboona Matricaria chamomila L, Hulba Trigonella foenum-graecum L.and Shuneez Nigella sativus L have been proven for their efficacy. Baboona Matricaria chamomilla L has been selected for the treatment of dysmenorrhea in the present study as it possess properties such as Mudirr i Hayd emmenagogue, Mudirr-i-Bawl diuretic, Idrar al-Laban lactagogue, Muhallil e Awram anti inflammatory, Musakkin analgesic, Daf i Tashannuj antispasmodic and Mufatche Suddad 9-12 Hence, oral administration in the form of Joshanda Baboona Matricaria chamomilla L and its sitz bath have been chosen to validate its efficacy in Usr al Tamth Tashanuji.
Abzan is a method where the patient sits in a shallow tub filled with plain or medicated water, covering up to the umbilicus. It is commonly advised by Unani physicians for gynecological disorders such as menstrual disorders, genital prolapse, vaginal infections a pelvic inflammatory disease. |