| CTRI Number |
CTRI/2023/07/055083 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Pandu (Iron Deficiency Anemia) through Ayurveda. |
|
Scientific Title of Study
|
A Comparative Study To Evaluate The Efficacy Of Ashtaguna Manda And Punarnava Mandura In The Management Of Raktalpata W.S.R. To Pandu ( Iron Deficiency Anemia). |
| 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 Sheetal S Mahadik |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra |
| Address |
Room No. 63,Department of Swasthavritta and Yoga , Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9468475757 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal S Mahadik |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra |
| Address |
Room No. 63,Department of Swasthavritta and Yoga , Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra
HARYANA
136118
India |
| Phone |
9468475757 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal S Mahadik |
| Designation |
Associate Professor |
| Affiliation |
Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra |
| Address |
Room No. 63,Department of Swasthavritta and Yoga , Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra
HARYANA
136118
India |
| Phone |
9468475757 |
| Fax |
|
| Email |
shitalsingla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Government Ayurvedic College and Hospital , Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Dr Prateek Khatana |
| Address |
OPD No 2,Swasthavritta and Yoga , Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra |
| Type of Sponsor |
Other [Self] |
|
|
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 Prateek Khatana |
Shri Krishna Government Ayurvedic College and Hospital |
OPD No.2, Swasthavritta and Yoga ,Shri Krishna Government Ayurvedic College and Hospital,Kurukshetra Pin 136118
Kurukshetra
HARYANA |
7009701562
prateek.khatana100@gmail.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:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashtaguna Manda, Reference: Sharangdhar samhita, Madhyama khanda , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -Ashtaguna Manda -Ahara Kalpana | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnava Mandura, Reference: Charka Samhita, Chikitsa Sthana 16, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the 18 to 50 years of age.
2.Patients fulfilling the diagnostic criteria of Iron Deficiency Anemia will be selected irrespective of cast religion and profession.
3.Patients with hemoglobin level between 7 to 10 gm%.
|
|
| ExclusionCriteria |
| Details |
1.Patients having age below 18 years and more than 50 yrs.
2.Patients having Thalassemia , Sickle cell Anemia , Leukamia and Aplastic or Hypoplastic Anemia.
3.Patient with bleeding piles.
4.Patient with chronic systematic illness( cardiac disease, cirrhosis of liver, diabetes mellitus , chronic kidney diseases, hypertension).
5.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To Evaluate The Efficacy Of Ashtaguna Manda And Punarnava Mandura In The Management Of Raktalpata W.S.R. To Pandu ( Iron Deficiency Anemia).
2.Change in Subjective & Objective Parameters in Pandu |
66 Days.
Follow up will be done 0n 7th day, 14th day, 21st day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To Study Pandu from various ayurvedic texts.
2 Correlation Of Raktalpata w.s.r.Pandu (Iron Deficiency Anemia) |
66 Days.
Follow up will be done on 7th day,14th day & 21st 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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/07/2023 |
| 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="1"
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
|
According to the World Health Organization (WHO), there are two billion people with anemia in the world and half of the anemia is due to iron deficiency. Anemia is a late indicator of iron deficiency, so it is estimated that the prevalence of iron deficiency is 2.5 times that of anemia. The estimated prevalence of anemia in developing countries is 39% in children <5 years, 48% in children of 5- 14 years, 42% in women of 15-59 years, 30% in men 15-59 years, and 45% in adults >60 years. These staggering figures have important economic and health consequences for low- and middle- income countries. Anaemia and iron deficiency lead to substantial physical productivity losses in adults. The nearest correlation of iron deficiency anemia (IDA) can be made with Pandu in Ayurveda considering its main Lakshana which is Raktalpata.
Iron preparation provides satisfactory result in iron deficiency Anemia like ferrous sulfate, ferrous gluconate, fumarate and ferric hydroxide. They often leave metallic taste in mouth. Usually, these preparations are gastric irritant and have common side effects like nausea, abdominal pain and either constipation or diarrhea. To avoid these side effects and to fulfill the above needs, this clinical study for the efficacy of Ashtaguna Manda and Punarnava Mandura is designed. Ayurveda is a health science which treats diseases by both medicines and diet (Aushadh and Aahar). Just like medicines, diet is also used for treating disease and maintaining health. Food items which are used for treatment in Ayurveda are named as Pathya Kalpana.
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