| CTRI Number |
CTRI/2023/07/054770 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the efficacy of Full body steaming and Safoof Mohazil and Arq Zeera in patients with Obesity |
|
Scientific Title of Study
|
To study anti-obesity therapeutic effects of Tabkheer (full body Steaming) and safoof Mohazil with Arq Zeera in patients of Siman-e-Mufrat using Differential Transcriptional Expression Analysis- A Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arjumand Shah |
| Designation |
Research Officer |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Regional Research Institute of Unani Medicine Srinagar Naseem Bagh Campus Habak Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006180746 |
| Fax |
|
| Email |
dr.arjumandshah111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjumand Shah |
| Designation |
Research Officer |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Regional Research Institute of Unani Medicine Srinagar Naseem Bagh Campus Habak Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006180746 |
| Fax |
|
| Email |
dr.arjumandshah111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjumand Shah |
| Designation |
Research Officer |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Regional Research Institute of Unani Medicine Srinagar Naseem Bagh Campus Habak Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006180746 |
| Fax |
|
| Email |
dr.arjumandshah111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council For Research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine New Delhi |
| Address |
61-65 Institutional Area, Opp. D-Block,Janakpuri,New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Arjumand Shah |
Regional Research Institute of Unani Medicine |
Regional Research Institute of Unani Medicine ,OPD Sections
Srinagar
JAMMU & KASHMIR |
7006180746
dr.arjumandshah111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM Srinagar |
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 |
| Intervention |
Full Body steaming or Hammam Bukhari |
Hammam Bukhari (Steam bath) is one of the Unani regimens which is very effective way of getting rid of excess fat deposition through prespiration.
Full body steaming shall be given biweekly for a period of 90 Days in one group
|
| Comparator Agent |
Safuf Mohazil and Arq Zeera |
Safoof Mohazil is a compound Unani formulation which has the following five herbs in it
1)Tukhme badyan (Foeniculum vulgare) 1 g
2)Nankhwa (Trachyspermum ammi) 1 g
3)Zeera Siyah (Carum carvi) 1 g
4)Sudab (Ruta graveolens) 1 g
5)Marzanjosh (Origanum vulgare) 0.25 g
one animal origin drug
6)Luc Magsool (purified stick lac) 0.5 g
and a mineral origin drug
7)Bura Armani (Borax) 0.25 g
Arq Zeera is also another Unani formulation in distillate form prepared from the following herbs
1)Zingiber Officinale Roxb,
2)Carum Carvi L,
3)Cuminum Cyminuml ,
4)Trachyspermum ammil,
Sufoof Mohazil 7gm twice a day before breakfast and at 5pm in the evening before evening snack. Arq zeera 20ml with it orally shall be given to obesity patients in another group for 90 days
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with BMI>30
2)Waist circumference >102 cm in men>88cm in women
3)Patients who are ready of sign the informed consent ,follow the protocol and willing to participate in clinical study voluntarily
|
|
| ExclusionCriteria |
| Details |
1)Non-Cooperative patient
2)Patient below 20years and above 60years.
3)BMI<30
4)Patient who fail to give written consent.
5)Pregnant and lactating mothers.
6)Patients with local wounds and infections.
7)Unstable and mentally retarded patients.
8)Patients with portal hypertension, bleeding disorders, DM.
9)Hypothyroidism,
10)Hormonal imbalance,
11)Cardiovascular diseases,
12)Hemiplegia associated with
13)Severe hypertension,
14)Very obese patients having BMI more than 45.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Height & weight measurement
2)Circumferences of fatty parts (chest, abdomen, hip, mid arm, forearm, & mid-thigh before and after treatment.
3)Walking time the time taken to climb fixed number of stairs in seconds was taken as walking time.
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Decrease in Weight reduction
2)Decrease in chest circumference
|
90 Days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
20/07/2023 |
| 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="2"
Months="0"
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
|
Obesity is a chronic lifestyle disease. Despite all modern advances in medicine an effective drug treatment of obesity has not been found yet. Unani physicians have categorized Saman-e-Mufrat as a balghami (phlegmatic) disease wherein the Hararat e gharizya (Innate heat) is decreased. Unani physicians have recommended Tabkheer (steam bath) which is a regimen employed to increase Hararat e gharizya (Innate heat).Also many drugs have been suggested by unani physicians as a treatment for obesity . Among such medicines Safoof Mohazil and Arq Zeera are considered to be known anti-obesity drugs which have been proved by many preclinical and clinical studies. However a research to explain the underlying mechanism of action and molecular pathways of both the therapy(Tabkheer) as well as anti-obesity unani drugs remains obscure. Therefore, in this pilot study, an attempt will be made to elucidate and compare the molecular mechanism of action of Tabkheer(Steam Bath) with Unani drugs Safoof Mohazil and Arq zeera for the treatment of obesity. Also this trial is planned to evaluate the efficacy of Tabkheer with classical anti-obesity Unani drugs viz. Safoof Mohazil & Arq zeera in Saman-e-Mufrat (Obesity). |