| CTRI Number |
CTRI/2024/04/066525 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anaemia in pregnancy |
|
Scientific Title of Study
|
Clinical Study of Iron Deficiency Anaemia in Pregnancy (Adam-e-Damviat Douran-e-Hamal) and its Management With Unani Drug |
| 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 khurathulien shaista |
| Designation |
Pg Scholor |
| Affiliation |
Govt. Nizamia Tibbi College and General Hospital |
| Address |
Pg Department of Obstetrics and Gynecology(Ilmul Qabalat wa Amraz-e-Niswan)
Govt. Nizamia Tibbi College and General Hospital, Hyderabad,Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9985348587 |
| Fax |
|
| Email |
amtul1231@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Suhasini |
| Designation |
Professor |
| Affiliation |
Govt. Nizamia Tibbi College and General Hospital |
| Address |
Pg Department of Obstetrics and Gynecology (Ilmul Qabalat wa Amraz-e-Niswan)
Govt. Nizamia Tibbi College and General Hospital, Hyderabad, charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9949586899 |
| Fax |
|
| Email |
drasuhasini12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Suhasini |
| Designation |
Professor |
| Affiliation |
Govt. Nizamia Tibbi College and General Hospital |
| Address |
Pg Department of Obstetrics and Gynecology (Ilmul Qabalat wa Amraz-e-Niswan)
Govt. Nizamia Tibbi College and General Hospital, Hyderabad, charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9949586899 |
| Fax |
|
| Email |
drasuhasini12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, India,500002 |
|
|
Primary Sponsor
|
| Name |
Pg Department of Obstetrics and Gynecology ( Ilmul Qabalat wa Amraz e Niswan) |
| Address |
Govt. Nizamia Tibbi College and General Hospital, charminar, Hyderabad,Telangana,India,500002 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Govt Nizamia Tibbi College and General Hospital |
Pg Department of Obstetrics and Gynecology ( Ilmul Qabalat wa Amraz e Niswan), Govt. Nizamia Tibbi College and General Hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khurathulien Shaista |
Govt Nizamia Tibbi College and.General Hospital |
Pg Department of Obstetrics and Gynecology
(Ilmul Qabalat wa Amraz e Niswan), Charminar,
Hyderabad,
Telangana,
India, 500002
Hyderabad
TELANGANA |
9985348587
amtul1231@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt Nizamia Tibbi College and General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Sharbat e Unnab |
Oral Administration of Sharbat e Unnab 10ml Morning and Evening for 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Female |
| Details |
Both Primi and Multi Gravidae Between Gestational Age 20 Weeks-32 Weeks.
Hb% Levels Between 8g/dl-10g/dl |
|
| ExclusionCriteria |
| Details |
Patients With Severe Oligohydramnios
Patients Having Systematic Diseases Such as Diabetes Mellitus, Hypertension, Renal Disorders, Cardiac Disorders, Haemolytic Disorders, Malignancy and Tumors |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Minimize The Maternal and Fetal complications in Anaemia During Pregnancy |
Each Patient outcomes Depends After 3 Months of Oral Administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate the Effect of Unani Drug
To Increase The Haemoglobin level
To Increase The Serum Ferritin value |
Each Patient outcomes Depends after 3 Months of Oral Administration |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/05/2024 |
| 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="0"
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
|
Anaemia is a haematological condition characterised by the reduction in the concentration of haemoglobin accompanied by reduced number of circulating rbc.The modest fall in haemoglobin levels during pregnancy is caused by a relatively greater expansion of plasma volume compared with the increase in red cell volume. INCIDENCE:The frequency of anaemia during pregnancy depends primarily on preexisting iron states and prenatal supplementation. PATHOGENESIS:Iron deficiency anaemia develops when the supply of iron is inadequate, the factors which lead to development of anaemia during pregnancy are:-
Iron deficiency anaemia develops when the supply of iron is inadequate, the factors which develop anaemia during pregnancy are: l Increase demand of iron l Disturbed metabolism l Pre-pregnant health status .
MATERNAL COMPLICATION: l Pre-eclampsia l Poor lactation l Pulmonary embolism l Preterm labour l Postpartum haemorrhage l Cardiac failure, shock FOETAL COMPLICATION: l Still birth l Low birth weight baby l Preterm iugr baby. In unani literature various synonyms of anaemia are termed as faqr-ud-dam, soo-ul-qiniya, qillat-ud-dam, kami-e-khoon, fasaad-e-khoon, adam-e-damviat. Acoording to akseer e azam faqr-ud-dam is an arabic word which means shortage of blood. Soo-ul-qiniya means deficiency in storage. SHAIK-UR-RAYEEES ABU ALI SENA in his book “Al-Qanoon†explained that alteration in the temperament of liver causes its weakness which leads to soo-ul-qiniya. Symptoms like Puffiness of the face, oedema on lower and upper extremities, body becomes pale, constipation, loss of sleep can be seen. HAKEEM MOHAMMED ARZANI in his book “TIB-E-AKBAR†said that flatulence or altered diarrhoea, constipation, disturbance in sleep are seen in anaemia. |