| CTRI Number |
CTRI/2025/07/091320 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate The Therapeutic effect Of Unani Formulation(Sandroos With Sikanjabeen) in Cases Of Obesity (Siman Mufrit) |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy and safety of Unani formulation (Sandroos and Sikanjabin) in the management of Siman Mufrit (Obesity) (IUMT-5.13.87) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AYSHA KHATOON |
| Designation |
PG SCHOLAR |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Moalajat State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
7052875225 |
| Fax |
|
| Email |
ayshakhatoon1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Qadir |
| Designation |
Reader |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Moalajat State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9415757169 |
| Fax |
|
| Email |
aq.ayaz5775@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Zubair |
| Designation |
Lecturer |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Moalajat State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8318016554 |
| Fax |
|
| Email |
mzaligmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut Tib College and Hospital, Near Ramabai Railly Sthal, Lucknow, UTTAR PRADESH - 226025, India |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut Tib College And Hospital |
| Address |
Near Ramabai Railly Sthal Lucknow 226025 |
| 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 AYSHA KHATOON |
State Takmeel ut Tib College and Hospital |
Department of Moalajat, Near Ramabai Railly Sthal, Lucknow, UTTAR PRADESH - 226025
Lucknow
UTTAR PRADESH |
07052875225
ayshakhatoon1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Takmeel ut Tib College And Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Unani Formulation
Sandroos and Sikanjabin |
1. Sandroos-
DosageForm:Safuf (Powder)
Dose:2.5 gm once daily
Route of administration: Oral
Duration of protocol therapy:06 weeks
2. Sikanjabin
Dosage form: Sharbat
Dose:25 ml once daily
Route of administration: oral
Duration of protocol therapy:06 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically diagnosed Siman Mufrit (obesity) of either sex
Patients belonging to 18-60 years of age
Patients having BMI between 25-35kg m2
Patient able to participate in the study and ready to follow the instructions and sign the consent form.
|
|
| ExclusionCriteria |
| Details |
Patient below the age of 18 and above the age of 60.
Pregnancy and lactating mother & women using OCP drug.
Patients with systemic and other metabolic diseases.
Patients having BMI more than 35kg m2.
Patients who refuse to give the written informed consent for the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in body weight
Reduction in BMI
Improvement in Total Sign and Symptoms Score |
Baseline , 2nd, 4th and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement In the Quality of Life |
Baseline ,2nd ,4th and 6th week |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
26/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title:"A Clinical Study to Evaluate the Efficacy & Safety of Unani Formulation (Sandroos with Sikanjabeen) in the Management of Siman Mufrit (Obesity)"
Researcher:
Dr. Aysha Khatoon, PG Scholar
Department of Moalajat, State Takmeel-ut-Tib College & Hospital, Lucknow
Objective:
To assess the efficacy and safety of a Unani formulation (Sandroos with Sikanjabin) in the treatment of Siman Mufrit (Obesity).
Background:
Obesity is a growing global health concern, recognized by WHO as a chronic disease. It is characterized by excessive fat accumulation that impairs health and increases risk for several conditions such as diabetes, cardiovascular diseases, and hormonal disorders. In Unani medicine, obesity (Siman Mufrit) is viewed as a Balghami (phlegmatic) disorder due to cold temperament and metabolic imbalance.
Unani Perspective:
Unani texts attribute obesity to causes like oily food (Tar Ghiza), sedentary lifestyle, and cold temperament (Sue Mizaj Barid). Management involves correcting temperament, eliminating excess phlegm, and enhancing metabolism using hot-dry temperament herbs.
Formulation Used:
-
Sandroos (Trachylobium hornemannianum) – powder form (2.5 gm/day)
-
Sikanjabin – sweet-sour syrup (25 ml/day)
These are selected for their muhazzil (emaciating), muhallil (resolvent), and diuretic properties.
Methodology:
-
Study Design: Single-arm pre-post interventional trial
-
Sample Size: 38 patients (aged 18–60) with BMI between 25–35 kg/m²
-
Duration: 42 days of treatment with 18 months total study time
-
Inclusion/Exclusion Criteria: Standard criteria based on age, BMI, health status, and informed consent
Assessment Parameters:
-
Reduction in body weight and BMI
-
Improvement in signs/symptoms (e.g., joint pain, dyspnea, lethargy)
-
Laboratory safety parameters (CBC, LFT, RFT, RBS)
-
Adverse effects monitoring
Conclusion (Proposed):
The trial aims to provide evidence for the scientific validation of traditional Unani treatments for obesity, ensuring both efficacy and safety in a controlled clinical setting.
Let me know if you’d like a slide presentation summary, literature review points, or Unani treatment details extracted from this synopsis. |