| CTRI Number |
CTRI/2024/10/074747 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Iron deficiency anemia in reproductive age. |
|
Scientific Title of Study
|
A clinical evaluation of Dawa ul kurkum Kabir and Qurs kushta Folad in Su-al-qinya bawajah qilat Folad (Iron deficiency anemia) among women of reproductive age. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariya fatema |
| Designation |
MS student |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi |
| Address |
Dept of Ilmul Qabalat Wa Amraz-e-Niswan OPD no14 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi
New Delhi
DELHI
110005
India |
| Phone |
8669155972 |
| Fax |
|
| Email |
mariyafatema38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahana Ayub |
| Designation |
Assistant Professor and Supervisor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi |
| Address |
Dept of Ilmul Qabalat Wa Amraz-e-Niswan OPD no 14 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi
New Delhi
DELHI
110005
India |
| Phone |
7037881205 |
| Fax |
|
| Email |
shahanaayub86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariya fatema |
| Designation |
MS student |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi |
| Address |
Dept of Ilmul Qabalat Wa Amraz-e-Niswan OPD no14 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi
New Delhi
DELHI
110005
India |
| Phone |
8669155972 |
| Fax |
|
| Email |
mariyafatema38@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi -110005 India |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi -110005 India |
| 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 Mariya fatema |
Ayurvedic and Unani Tibbia College and Hospital |
OPD no 14 Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh NewDelhi
New Delhi
DELHI |
8669155972
mariyafatema38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College and Hospital Internal Ethical Committee for MD/MS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dawa-Ul-kurkum Kabir and Qurs kushta Folad |
Dawa-Ul-kurkum kabir 5gm along with 2 Qurs Kushta Folad (130mg) OD For 2 months |
| Comparator Agent |
Qurs kushta Folad |
2 tab 130mg OD For 2 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women of reproductive age having mild(Hb 11-11.9 hm/dl) to moderate(Hb 8-10.9gm/dl) anemia
Anemia with or without heavy irregular menses
Women of reproductive age(15-45yr) having complaint of Pallor, weakness, fatigue, breathlessness on exertion, palpitation, anorexia, angular stomatitis, glossitis, edema, koilonychia, dizziness and fainting
|
|
| ExclusionCriteria |
| Details |
Women having Hb less than 8gm/dl and more than 11.9gm/dl
Women having history of acute blood loss and chronic disease requiring long term treatment
Women of age less than 15yr and more than 45yr
Women having cardiovascular, renal, hepatic disease |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Hb% and PCV measured at 8wks from the baseline |
2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in sign and symptoms of iron deficiency anemia
Changes in RBC count MCV, MCH, MCHC measured at 8wks from the baseline |
8wks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/10/2024 |
| 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="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 present views and reviews provides an overview on IDA in women’s health, Iron deficiency anemias high prevalence in women’s & describes the background on iron metabolism, pathogenetic mechanisms, including a focus on heavy menstrual bleeding & uterine disorders. Despite the high prevalence of IDA in reproductive aged women & it’s the impact on quality of life of women it remains undiagnosed and untreated as we focus on managing women’s heavy menstrual bleeding and uterine disorders and assume that primary care clinicians are treating the associated IDA.
We now need to take the lead in diagnosis, management and initiate early treatment for IDA in reproductive aged women’s.
Oral iron supplements (Ferric citrate, ferric maltol, ferrous fumarate, ferrous gluconate, ferrous sulfate, polysaccharide iron complexes) are well known and established remedy for IDA. However, adverse effect are abound. These include constipation or sometimes diarrhea, metallic taste, gastric irritation, and thick green tenacious stool. As previously pointed out, more than 75% of those to whom it is prescribed report significant gastrointestinal irritation. In view of this it is the need of the present era to evaluate the efficacy of unani drugs in IDA in reproductive aged women which is safe and cost effective.
Secondly, according to the Unani concept the main cause of Su-al-qiniya is Zofe jigar and Sue mizaj jigar barid, in which hepatic processing of food becomes disturb and liver fails to prepare mature blood, instead more phlegm is formed. So with passage of time more and more phlegm accumulate in blood as well as in the body. This phlegm interfere with normal blood flow as a result nutrition as well as delivery of Arwah (pneuma) to different parts of body get disturbed. As per Unani concept adequate heat is mandatory in liver, to prepare mature khoon (humours/blood). In reference to this Unani concept of Su-al-qiniya Dawa ul kurkum Kabir is an ancient saffron-based polyherbal formulation which is a promising unani formulation for Amraz-e-barida of Jigar, Zofe jigar and Su-al-qiniya as mentioned in Qarabadins. For this proposed study, Dawa ul kurkum Kabir and Qurs Kushta Folad (promising iron supplement) is taken. The Purpose of this study is to generate the safety and efficacy data of the above-mentioned combined therapy in the treatment of IDA in reproductive aged women’s on modern scientific parameters.
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