| CTRI Number |
CTRI/2026/02/104540 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of unani formulation in lump in breast. |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE MANAGEMENT OF SALA-E-SADI (FIBROADENOMA OF BREAST) WITH UNANI FORMULATION-AN OPEN LABEL SINGLE ARM TRIAL |
| 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 Kausar Jahan |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Amraze Niswan wa Qabalat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol bagh
Central
DELHI
110005
India |
| Phone |
8077716946 |
| Fax |
|
| Email |
kausarnafees42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aysha Raza |
| Designation |
Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Amraze Niswan wa Qabalat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol bagh
Central
DELHI
110005
India |
| Phone |
9354925031 |
| Fax |
|
| Email |
draysharaza11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aysha Raza |
| Designation |
Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Amraze Niswan wa Qabalat, Ayurvedic and Unani Tibbia College and Hospital, Ajmal khan road, Karol bagh
Central
DELHI
110005
India |
| Phone |
9354925031 |
| Fax |
|
| Email |
draysharaza11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital,Ajmal khan road, Karol Bagh, Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ajmal khan road, Karol Bagh, Delhi-110005 |
| 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 Kausar Jahan |
Ayurvedic and Unani Tibbia College & Hospital |
OPD No.14 and Maternity Block,Department of Amraze Niswan wa Qabalat,Ayurvedic and Unani Tibbia College & Hospital,Ajmal khan road, Karol Bagh, Delhi-110005
Central
DELHI |
8077716946
kausarnafees42@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
For Local Application
1.Tukhm Krafs(Apium graveolens) 2.Babuna(Matrica chamomilla) 3.Mako(Solanum nigrum) 4.Nakhoona(Trigonella uncata)
For Oral
1.Aftemoon (Cuscuta reflexa) 2.Bisfaij(Polypodium vulgare) 3.Sana Makki(Cassia augustifolia)4.Post Halila zard (Terminalia chebula) 5.Post Halila Kabli (Terminalia chebula) 6.Ustukhudus (Lavendula stoechas) 7.Turbud Safaid (Ipomea turpethum) 8.Maweez Munakka (Vitis vinifera) |
For Local Application:Coarse Powder of Tukhm Krafs,Babuna,Mako,Nakhoona after making a paste with plain water will be given to apply gently over the affected breast area at night once a week for 3 months as Zimad.
1.Tukhm Krafs (Apium graveolens): Which is Har Yabis (Hot & Dry)(2,2) in mizaj and possess the properties of qataye ratubat, Mudir-e-bol (Diuretics), Mudir-e-bol wa haiz (Emmenogauge and diuretics), Kasir-e-riyah (Carminative) part used is seed,3gms.
2.Babuna (Matrica chamomilla): Which is Har Yabis (Hot & Dry)(2,1) in mizaj and possess the properties of Muhallil-e-awram(anti-inflamatory), Mushil (Purgative) , Muqawwi-e-meda (Gastric tonic), Kasir-e-riyah (Carminative), Muqawwi-e-asab (Nervine tonic), Muqawwi-e-dimagh (Brain tonic), Mudir-e-bol wa haiz (Emmenogauge and diuretics), Daf-e-humma (Antipyretics) part used is flower,3gms.
3. Mako (Solanum nigrum): Which is Barid Yabis (Cold & Dry) in mizaj and possess the properties of Muhallil -e-awram (anti-inflammatory), Mudir-e-Bol (Diuretics), Rada mawad (Repellent matter), Qabiz (Astrigent) part used is fruits,3gms.
4. Nakhoona (Trigonella uncata): Which is Har Yabis (Hot & Dry)(2,1) in mizaj and possess the properties of Muhallil-e-awram (anti-inflammatory), Munzij-e-awram (Concotive of inflammation),part used is pods,3gms
For Oral:Nuskha Joshanda Aftemoon contents-
1.Bisfaij (Polypodium vulgare): which is Har Yabis (Hot & Dry)(2,2) in mizaj and possess the properties of Muhallil, Mushil-e-Balgam& sauda,part used is whole plant,35gms.
2. Aftemoon (Cuscuta reflexa): Which is Har Yabis (Hot & Dry)(2,2) in mizaj and possess the properties of Muhallil-e-awram (anti-inflammatory), Kasir-e-riyah (Carminative), Mushil-e-Balgam & sauda, Muqawe jigar (liver Tonic),part used is roots,17gms.
3. Sana Makki (Cassia augustifolia): Which is Har Yabis (Hot & Dry)(1,1) in mizaj and possess the properties of Mushil-e-akhlate salasa, musaffi Dam (blood purifier),part used is leaves,17gms.
4. Post Halila zard (Terminalia chebula): which is Barid Yabis (Cold & Dry)(1,3) in mizaj and possess the properties of Mushil safra,part used is flower,35gms.
5. Post Halila Kabli (Terminalia chebula): which is Barid Yabis (Cold & Dry)(1,3) in mizaj and possess the properties of Mushil-e-akhlate salasa part used is flower,35gms.
6. Ustukhudus (Lavendula stoechas): Which is Har Yabis(2,2) (Hot & Dry) in mizaj and possess the properties of Muhallil-e-awram (anti-inflammatory), Munzij-e-balgam & sauda, Munakki Dimag,part used is flower,35gms.
7. Turbud Safaid (Ipomea turpethum): Which is Har Yabis (Hot & Dry)(3,2) in mizaj and possess the properties of Musleh Balgam, Mukhrij Balgam Mushil-e-Akhlate muhariqa,part used is roots,17gms.
8. Maweez Munakka (Vitis vinifera): Which is Har Yabis (Hot & Dry) in mizaj and possess the properties of Jazibe ratubat, Jaali, Mufatte sadad,part used is fruits without seeds,35gms. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women of age group 15-40 years
Lumps size of 3 cm or less.
Upto BI RADS 2.
Married and unmarried both
Patient able to participate in the study and ready to follow the instruction and signed the informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient with h/o severe systemic diseases-DM, HIN, IHD, Renal disease.
Women below 15yrs and more than 40yrs of age.
BI RADS 0 & BI RADS 3 and above
Patient with h/o malignancy.
Pregnant and lactating women.
Patients on hormonal therapy.
Patient not following instruction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in fibroadenoma size before and after treatment. |
At baseline & at every 15th day till 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms (pain) |
At baseline & at every 15th day till 90 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/03/2026 |
| 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 Applicable |
| 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
|
Patients fulfilling the inclusion criteria will be enrolled in the study after obtaining the written informed consent. A detailed History will be evaluated with basic information of each patient, followed by examination, and assessment of objective parameters. Then patient will be given Test drug as mentioned. Patient will be instructed not to take any other medication during trial and report any adverse effects (if any), All findings will be recorded. After completion of trial all data that will be recorded will be statistically analysed. |