| 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
|
|
|
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
|
|
|
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. |