| CTRI Number |
CTRI/2022/11/047512 [Registered on: 22/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Draksha Avaleha and ferrous sulphate in the Management of Iron Deficiency Aaemia |
|
Scientific Title of Study
|
Nidana Panchatmaka Study Of Pandu Roga wrs to Iron Deficiency Anaemia and its Management with Drakshavaleha In Comparison to Ferrous Sulphate |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Manglesh |
| Designation |
H. O. D Department of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
RGGPG Ayurvedic college and Hospital paprola District Kangra |
| Address |
Room No 106 Department of Roga Nidana Evum Vikriti Vigyana RGGPG Ayurvedic College And Hospital Paprola District Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816324204 |
| Fax |
|
| Email |
drrkmanglesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Manglesh |
| Designation |
H. O. D Department of Roga Nidana Evum Vikriti Vigyana |
| Affiliation |
RGGPG Ayurvedic college and Hospital paprola District Kangra |
| Address |
Room No106 Department of Roga Nidana Evum Vikriti Vigyana RGGPG Ayurvedic College And Hospital Paprola District KangraHimachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816324204 |
| Fax |
|
| Email |
drrkmanglesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamini Spolia |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic college and Hospital paprola District Kangra |
| Address |
Room No105 Department of Roga Nidana Evum Vikriti Vigyana RGGPG Ayurvedic College And Hospital Paprola District Kangra, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6005619125 |
| Fax |
|
| Email |
kaminispolia3@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1. Charak pharmacy, RGGPG Ayurvedic college and Hospital Paprola.
2. ISM Jogindernagar |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and Hospital paprola district kangra HP |
| Address |
Principal Room, Admin Block, RGGPG Ayurvedic College And Hospital Paprola, District, HP 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajesh Manglesh |
RGGPG Ayurvedic college and Hospital and Hospital Paprola district Kangra HP 176115 |
OPD of roga Nidana Evum vikriti Vigyana room no 208 , RGGPG Ayurvedic college and Hospital Paprola
Kangra
HIMACHAL PRADESH |
9816324204
drrkmanglesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) RGGPG Ayurvedic college and Hospital paprola district Baijnath HP |
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(Iron Deficiency Anaemia ) , (2) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, (3) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Draksha Avaleha, Reference: Ashtang Hridya Pandu Roga Chitika Sthan Adhaya 16, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -with luke warm water), Additional Information: -Used in treatment of pandu roga | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous sulphate | Ferrous Sulphate 200mg tablet , Dosage :1 tablet Once a day after meals with water, Route : Oral, Used in treating Iron Deficiency Anaemia |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Individulas Who Comes Under The Criteria Of 16 to 60 Years
2.Blood Picture Presenting Either Microcytic Hypochromic Or Normocytic Hypochromic.
3.Anaemia In Pregnancy. |
|
| ExclusionCriteria |
| Details |
1.Anaemia Resulting From Acute or Chronic Blood Loss (Mennorhagia, DUB, Haemorrhoids)
2.Anaemia Resulting From Underlying Chronic Disorder Like Rheumatoid arthritis, Uraemia,Other Systemic Disorder , Thalasemia , Diabetes Mellitus , Hepatic Anaemia Cirhossis, Malignancy, Sideroblastic Anaemia |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Management Of Iron Deficiency Anaemia With Draksha Avaleha with its subjective and objective Criteria Fulfillment |
Within 8 weeks of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete Management and Relieve of symptoms of pandu roga |
8 weeks of trial |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/11/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the patients of pandu roga effect of draksha avaleha in group A( trial group)and effect of Ferrous sulphate on group 2( control group)will be assesed . Purpose of the trial is to compare or asses the effect of these two drugs and to evaluate which drugs works better and provide best result in patients of pandu roga and the aim is to cure pandu roga and symptoms associated with it. |