| CTRI Number |
CTRI/2022/11/047470 [Registered on: 21/11/2022] 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 Trial |
|
Public Title of Study
|
Comparative clinical study of godanti-gairika vati and godanti-kasisa vati in pandu ( iron deficiency anaemia) and pharmaceutico-analytical study of these two vati. |
|
Scientific Title of Study
|
A comparative pharmaceutico-analytical study of Godanti-Gairika vati & Godanti-Kasisa vati and its clinical effect in pandu roga w.s.r. to iron deficiency anaemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Ashwani Upadhyaya |
| Designation |
HOD Rasa shastra bhaishajya kalpana |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
HOD Room no 4 Rasa shastra deptt Charak govt Ayurvedic pharmacy block
RGGPG Ayurvedic College and Hospital paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418186116 |
| Fax |
|
| Email |
drashwani1963@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ashwani Upadhyaya |
| Designation |
HOD Rasa shastra bhaishajya kalpana |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra HP |
| Address |
HOD Room no 4 Rasa shastra deptt Charak Govt Ayurvedic pharmacy block
RGGPG Ayurvedic College and Hospital paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418186116 |
| Fax |
|
| Email |
drashwani1963@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjeeta Ramol |
| Designation |
2nd Yr PG Scholar Rasa shastra bhaishajya kalpana |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Rasa Shastra Bhaishajya Kalpana Deptt
Charak Govt Ayurvedic Pharmacy block
RGGPG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018047433 |
| Fax |
|
| Email |
dr.manjeeta.ramoul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Ayurvedic Pharmacy RGGPG Ayurvedic College and Hospital Paprola Distt. Kangra (HP), 176115 |
|
|
Primary Sponsor
|
| Name |
Principal, R.G.G.P.G. Ayurvedic College and Hospital Paprola, Distt. Kangra, H.P. |
| Address |
Principal Room, Administrative Block, R.G.G.P.G. Ayurvedic College and Hospital Paprola, Distt. Kangra, H.P. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Ashwani Upadhyaya |
H.O.D. Room No. 4, Deptt. Of Rasa shastra,Bhaishajya Kalpana R.G.G.P.G. Ayurvedic College and Hospital Paprola, Distt. Kangra |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manjeeta Ramol |
RGGPG Ayurvedic College And Hospital Paprola |
OPD 209, Rasa Shastra Bhaishajya Kalpana
Kangra
HIMACHAL PRADESH |
7018047433
dr.manjeeta.ramoul@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 |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Godanti Gairika vati, Reference: AFI Part 3, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -Drug should be taken preferably 2 hours after meal(2) Medicine Name: Godanti Kasisa vati, Reference: AFI Part 3, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -Drug should be taken preferably 2 hours after meal |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing for clinical trial and ready to give written consent.
2.Patients having Hb more than 8gm% but less than 10gm%.
3.Patients possessing sign and symptoms of Pandu roga on the basis of diagnostic criteria.
4.Patients not having any associated chronic ailment. |
|
| ExclusionCriteria |
| Details |
1.Patients having Hb less than 8gm% or more than 10 gm %.
2.Patients with further complications of Pandu roga such as hridroga, shotha etc.
3.Congenital anaemia like sideroblastic anaemia, congenital dyserythropoetic anaemia, thalessemia, sickle cell anaemia, aplastic anaemia etc.
4.Patients having blood loss due to haemorrhoids, ulcers and epistaxis.
5.Patients suffering from AIDS, Cancer, TB, Diabetes mellitus or any other severe systemic dissorder. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relieve in symptoms like palpitations, dryness, lack of sweating and fatigue, tinnitus, pallor, generalised weakness, vertigo, excessive sleep, pain in the calf muscle, swelling around the eye, anorexia. |
45 days trial period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complete remission of sign and symptoms.
Improved haemoglobin levels of patients. |
Follow up 1 month after completion 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="1"
Days="15" |
|
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
|
Among the patients of Pandu roga ( iron deficiency anaemia) the effect of Godanti-Gairika vati in group 1 and Godanti-Kasisa vati in group 2 will be assessed. The purpose of the trial is to compare the effect of these two drugs and to evaluate which drug works better and provide best result in the patients of Pandu roga and the aim is to cure Pandu roga and symptoms associated with it. |