| CTRI Number |
CTRI/2026/02/103038 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Secondary Dysmenorrhoea due to endometriosis |
|
Scientific Title of Study
|
Efficacy of unani formulation in the management of Secondary Dysmenorrhea due to Endometriosis |
| 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 Uzma Begum |
| Designation |
Pg scholar |
| Affiliation |
Govt Nizamia tibbi college and hospital. |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan op room no 08 new building Government Nizamia Tibbi College and hospital Charminar Hyderabad
Telangana 500002 Indian
Hyderabad
TELANGANA
500002
India |
| Phone |
8790188182 |
| Fax |
|
| Email |
ayezagntc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
Assistant Professor |
| Affiliation |
Government Nizamia Tibbi College and hospital |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan op room no 08 new building Government Nizamia Tibbi College and hospital Charminar Hyderabad
Telangana 500002 Indian
Hyderabad
TELANGANA
500002
India |
| Phone |
9492027082 |
| Fax |
|
| Email |
syedaabudunnisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uzma Begum |
| Designation |
Pg scholar |
| Affiliation |
Govt Nizamia tibbi college and hospital |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan op room no 08 new building Government Nizamia Tibbi College and hospital Charminar Hyderabad
Telangana 500002 Indian
Hyderabad
TELANGANA
500002
India |
| Phone |
8790188182 |
| Fax |
|
| Email |
ayezagntc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College |
| Address |
Govt Nizamia tibbi college and hospital Charminar Hyderabad Telangana |
| 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 Uzma begum |
Government Nizamia Tibbi college and Hospital |
Department of Ilmul Qabalat wa Amraz e Niswan op room no 08 new building Government Nizamia Tibbi College and hospital Charminar Hyderabad
Telangana 500002 India
Hyderabad
TELANGANA |
8790188182
ayezagntc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, GNTC, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
JOSHANDA OF BIRANJASIF AND ZIMAD |
JOSHANDA OF BIRANJASIF:
1.Biranjasif (Achillea millefolium).
ZIMAD:
1.Aab e Kaddu(Cucurbita
moschata)
2.Aab e Kasni
(Cichorium intybus L.)
3.Aab e Kishneez(Coriandrum
sativum).
4.Aab e Anab-us-Salab(Solanum nigrum L.).
5.Rogan e Gul e Surkh(Rosa damascene).
Joshanda e Biranjasif orally twice for 20 Days with no other oral medication.
Patients will be given 10ml of Joshanda Biranjasif in two divided doses of 10ml in morning and 10ml in evening before food for 20 days before 3 days of menses for 3 consecutive cycles.
Zimad on the supra pubic region for 3 consecutive cycles
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
•Unmarried and Married.
•Patients are having pain abdomen diagnosed by USG whole abdomen and pelvis as endometriosis.
•Patients who are ready to participate in the study and who are willing to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Other Pelvic Conditions like known cases of Uterine fibroids and polyps or ovarian tumors.
Recent Surgical Intervention: Recent pelvic surgery (typically within 3–6 months period)
Severe Medical Comorbidities like uncontrolled
1.DM
2.HTN
3.Cardiac failure and Renal failure
Any condition that may interfere with study participation or drug metabolism (e.g. 1.severe liver disease 2. cancer and 3.psychiatric disorders).
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome to reduce dysmenorrhea.
Reduction in pain intensity measured by VAS (visual analogue scale) in each consecutive cycle before and after the intervention. VAS Score ranging between 3-7.
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes can be seen in the endometriotic size by USG will be measured.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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
|
Endometriosis is a chronic, estrogen dependent inflammatory condition characterized by the presence of ectopic endometrial tissue outside the uterine cavity, most commonly on the ovaries, fallopian tubes, peritoneum and other pelvic organs. This condition causes severe menstrual cramps, heavy bleeding, pain while defecation, Infertility, and serves as a potential indicator of underlying hormonal imbalance and some studies suggest that endometriosis increases the risk of ovarian cancer. Endometriosis is very common condition effecting 1 in every 10 females worldwide. And it’s often diagnosed in females between age 20 to 40. It can also happen to younger people in their teenage years. The symptoms of Endometriosis are manageable with proper treatment. Among the therapeutic approaches considered for endometriosis, pharmacological interventions using synthetic hormones have been adopted. These treatments aim to restore menstrual regularity and alleviate the associated symptoms. However, Concerns regarding side effects, long term hormones use causing premature menopause in women, and patient preferences have led researchers and clinicians to explore an alternative to this treatment. Despite the availability of symptomatic treatments there is currently no permanent cure for endometriosis highlighting the urgent for early diagnosis, better therapeutic options and comprehensive management strategies. Traditional systems of Unani medicine can offer valuable complementary approaches focusing on correcting bodily imbalance and improving overall well-being. Addressing endometriosis is essential to enhance women’s reproductive health, prevent painful menstruation, avoid complications and improve their overall quality of life. The exact pathogenesis of endometriosis remains unclear, and current treatment options—ranging from hormonal therapy to surgical intervention—often provide only temporary relief, with high recurrence rates. Moreover, many therapies carry significant side effects and are not suitable for long-term use, particularly in women seeking to preserve fertility. Given the complex nature and broad clinical spectrum of endometriosis, there is a significant need for further research to: Evaluate the effectiveness of therapeutic interventions. This study aims to address these gaps by inserting specific objective of the study here.eg., assessing awareness among patients, evaluating a specific treatment, or analyzing patterns in clinical presentation. By contributing to the existing body of knowledge, this research has the potential to inform better diagnostic, therapeutic, and supportive strategies for individuals suffering from endometriosis. In view of the importance of Endometriosis due to hyper estrogen increasing levels of cytokines, the increasing prevalence of infertility and early menopause and limitation in current treatment options, I decided to search for a safe and effective intervention in the treatment of endometriosis.
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