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CTRI Number  CTRI/2023/08/057087 [Registered on: 30/08/2023] Trial Registered Prospectively
Last Modified On: 30/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the effect of exercise, massage with Roghan-e-Baboona and wet fomentation on abdominal fat reduction following delivery  
Scientific Title of Study   A Comparative Clinical Trial to assess the effect of Riyazat, Dalak with Roghan-e-Baboona and Takmeed-e-Ratab on Postpartum Belly Fat 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sana Jameel 
Designation  PG Scholar 
Affiliation  Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh 
Address  Department of Amraz e Niswan wa Atfal Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh 202001

Aligarh
UTTAR PRADESH
202001
India 
Phone  6397072035  
Fax    
Email  Sanajameelaktc95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Suboohi Mustafa 
Designation  professor 
Affiliation  Ajmal Khan Tibbiya College 
Address  Department of Amraz e niswan wa atfal Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9411413788  
Fax    
Email  drsuboohi_m@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Suboohi Mustafa 
Designation  professor 
Affiliation  Ajmal Khan Tibbiya College 
Address  Department of Amraz e niswan wa atfal Ajmal Khan Tibbiya College and Hospital Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9411413788  
Fax    
Email  drsuboohi_m@yahoo.com  
 
Source of Monetary or Material Support  
Department of Amraz e niswan wa atfal Ajmal Khan Tibbiya College and Hospital faculty of Unani Medicine AMU Aligarh 
 
Primary Sponsor  
Name  Department of Amraz e Niswan wa Atfal Ajmal Khan Tibbiya College and Hospital 
Address  Department of Amraz e Niswan wa Atfal Ajmal Khan Tibbiya College and Hospital Aligarh muslim University Aligarh 202002 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PROFSUBOOHI MUSTAFA  Ajmal khan Tibbiya college and hospital  OPD NO.4 and IPD of Department of Amraz e Niswan wa Atfal Ajm Faculty of Unani Medicine AMU Aligarh
Aligarh
UTTAR PRADESH 
9411413788

drsuboohi_m@yahooo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abdominal exercise and fomentation with warm water followed by abdominal massage with petroleum jelly  Abdominal exercise twice a day and fomentation with warm water followed by massage with petroleum jelly every alternate day for 6 weeks 
Intervention  Riyazat Takmeed e Ratab with decoction of Banafsha Khatmi Akleelul malik Baboona and Dalak with Roghan e Baboona  Abdominal exercise twice a day Takmeed e ratab with decoction of Banafsha Khatmi Akleelul malik Baboona followed by abdominal massage with Roghan e Baboona for 3 alternate days in a week for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patients with normal vaginal delivery
Patients following 4th postpartum day upto the period of Lactational Amenorrhoea
Patients willing to take part in study 
 
ExclusionCriteria 
Details  Gross abdominal and pelvic pathology
Patients with tuberculosis, pregnancy induced hypertension, gestational diabetes
Patients following cesarean section
Pregnant women 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Waist circumference decreases
Waist to Hip ratio decreases
Skinfold thickness decreases 
Assessment of all parameters at the initiation of the study at 0 day 7th day 14th day 21st day 28th day 35th day & 42nd day  
 
Secondary Outcome  
Outcome  TimePoints 
Maternal Postpartum Quality of Life Questionnaire
Low Backache 
Assessment of all symptoms at the initiation of the study at 0 day 7th day 14th day 21st day 28th day 35th day & 42nd day  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/09/2023 
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="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  

The Postnatal period is defined as the first six weeks after birth. It is critical to the health and survival of a mother and her newborn. Common problems during postpartum period are-backache belly fat perineal pain bowel problems mastitis psychological problems such as postpartum depression postpartum haemorrhage thromboembolism post natal anemia. Abdominal muscles may be both morphologically and functionally affected by pregnancy. Dysfunction of the muscles can lead to persistent postpartum low back pain which may result in difficulty returning to daily life and activities after childbirth. Visceral(or intra-abdominal) fat is more metabolically active than fat depots in other body areas and is linked to a more adverse cardiometabolic profile. Visceral fat is associated with an increased risk of obesity related insulin resistance, cardio vascular disease lower high density lipoprotein cholesterol levels and progression of type2 diabetes  particularly among women. This visceral fatal is also contribute in the postpartum weight retention. In a study, it was seen that 91.3 percent retained weight near to one year post delivery while 8.7percent of mothers had either reduced their weight or had maintained the same weight as compared to pre-pregnancy weight. In a study the prevalence of central obesity are defined by waist circumference waist-hip ratio waist-hip-thigh ratio were 66.3 percent 62.1 percent and 50.6 percent respectively.

The modern management includes advising adequate breastfeeding.  Postpartum massage Post natal exercises which includes abdominal exercise pelvic floor exercise and wearing a post partum girdle are advice to the patient.

In Unani system of medicine for the purpose of tehleel-e-badan Hamaam Riyazat Dalak with roghan-e-mohallil and dietotherapy is advised.

Postpartum belly fat remains under evaluated and under managed while evidence is growing that postpartum treatments strongly influence patients  outcome .In present scenario there is less awareness concerning the benefits of exercise and massage in the postpartum womens quality of life. Therefore the aim of this study is to explore the effect of exercise and massage with roghan-e-mohallil on postpartum belly reduction.

 
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