| CTRI Number |
CTRI/2020/12/029673 [Registered on: 09/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Herbomineral Compound and Satwa] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Herbo-Mineral Compound and Guduchi Satwa in Sickle Cell Anaemia |
|
Scientific Title of Study
|
Clinico- Pathological Study On a Herbo-Mineral Compound And Guduchi Satwa On Sickle Cell Anemia W.S.R. To Sannipatika Pandu |
| Trial Acronym |
HMCGS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dusmanta Kumar Majhi |
| Designation |
P G Scholar |
| Affiliation |
Government Ayurvedic College & Hospital, Balangir |
| Address |
Department of Roga Nidana Evam Vikriti Vigyana
Government Ayurvedic College and Hospital
Balangir
Balangir
ORISSA
767001
India |
| Phone |
9668289599 |
| Fax |
|
| Email |
herbomineral02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Utkalini Nayak |
| Designation |
Reader |
| Affiliation |
Government Ayurvedic College & Hospital, Balangir |
| Address |
Department of Roga Nidana Evam Vikriti Vigyana
Government Ayurvedic College and Hospital
Balangir
Balangir
ORISSA
767001
India |
| Phone |
8847810890 |
| Fax |
|
| Email |
utkalini2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Utkalini Nayak |
| Designation |
Reader |
| Affiliation |
Government Ayurvedic College & Hospital, Balangir |
| Address |
Department of Roga Nidana Evam Vikriti Vigyana
Government Ayurvedic College and Hospital
Balangir
Balangir
ORISSA
767001
India |
| Phone |
8847810890 |
| Fax |
|
| Email |
utkalini2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dusmantakumar Majhi
P.G. Department of Roga Nidana Evam Vikriti Vigyana
Government Ayurvedic College and Hospital
Balangir
|
|
|
Primary Sponsor
|
| Name |
Dusmanta Kumar Majhi |
| Address |
PG Department of Roga Nidana Evam Vikriti Vigyana,
Government Ayurvedic College & Hospital, Balangir
Pin- 767001, Odisha
India |
| Type of Sponsor |
Other [Government Ayurveda College and Hospital, Balangir] |
|
|
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 Utkalini Nayak |
Government Ayurvedic College & Hospital, Balangir |
OPD and IPD of Government Ayurvedic College & Hospital, Balangir
Balangir
ORISSA |
9668289599
herbomineral02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurvedic College & Hospital, Balangir |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D578||Other sickle-cell disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guduchi Satwa |
Guduchi Satwa
500mg twice daily before food with Madhu for 30 days |
| Intervention |
Herbo-Mineral Compound |
Herbo-Mineral Compound
500mg twice daily before food with Madhu for 30 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients having clinical features of Pandu
(Anaemia) along with positive Sickling test.
b) Hemoglobin more than 6gm/dl.
c) Patients not having piles or hemorrhoids,
anal fissure or local infection in anal
canal.
d) Age group in between 12 to 60 years.
|
|
| ExclusionCriteria |
| Details |
a) Age less than 12 and more than 60 years.
b) Hemoglobin less than 6 gm/dl.
c) Anaemia induced by drugs.
d) Anaemia associated with underlying diseases
like malignancy and any life threatening
condition.
e) Pregnant and lactating women.
f) Patients taking immuno-suppressive medicines
like steroids etc.
g) Patients having Viral Hepatitis, Aplastic
Anaemia, Osteoporosis, Osteopenia,will be
excluded from the study.
h) Organ failure and other complication.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Symptoms-Panduta, Durvalata, Sadana, Angamarda, Jwara, Swasa, Aruchi, Gourava, Chhardi, Mala-mutra & Netraswetata |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Herbo-Mineral Compound is more effective than Guduchi Satwa |
31 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 1 |
|
Date of First Enrollment (India)
|
10/12/2020 |
| 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
|
This study will be submitted in the form of Dissertation to Sambalpur University as a part of Post graduate course |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Clinico pathological study on Herbo-Mineral compound and Guduchi Satwa on Sickle cell Anemia w.s.r. to Sannipatika Pandu. This is Done compulsory part of Postgraduate Course.Total number of patients to be studied is 30 with duration of 30 days. |