| CTRI Number |
CTRI/2025/08/093549 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Study |
| Study Design |
Other |
|
Public Title of Study
|
Nidanpanchak of Sickle Cell Disease as an Anukta Vyadhi |
|
Scientific Title of Study
|
Observational Study on Nidanpanchak of Sickle Cell Disease as an Anukta Vyadhi |
| 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 Dhananjay V Hange |
| Designation |
Ph.D Scholar |
| Affiliation |
Government Ayurved College and Hospital ,Nagpur |
| Address |
Department of Rog Nidan and Vikruti Vigyan
Government Ayurved College and Hospital Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822246598 |
| Fax |
|
| Email |
drdvhange@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanshyam Kodwani |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital ,Nagpur |
| Address |
Department of Rog Nidan and Vikruti Vigyan OPD no 40
Government Ayurved College and Hospital Sakkardara Nagpur,Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422121546 |
| Fax |
|
| Email |
drkodwani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhananjay V Hange |
| Designation |
Ph.D Scholar |
| Affiliation |
Government Ayurved College and Hospital ,Nagpur |
| Address |
Department of Rog Nidan and Vikruti Vigyan
Government Ayurved College and Hospital Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822246598 |
| Fax |
|
| Email |
drdvhange@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Ayurved College and Hospital Rajeraghuji Nagar ,Sakkardara Nagpur,India 440024 |
|
|
Primary Sponsor
|
| Name |
Dr Dhananjay V Hange |
| Address |
Departmet of Rog Nidan and Vikuti Vigyan
Goverment Ayurved College and Hospital Kamla Nehru Road Sakkardara Chowk Raje Raghuji Nagar Ayurvedic Layout Nagpur Maharashtra 440024 |
| 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 Dhananjay V Hange |
Goverment Ayurved College and Hospital Nagpur |
Department of Rog nidan and Vikruti Vigyan
Government Ayurved College and Hospital Kamla Nahru Road,Sakkardara
Chowk Raje Raghuji Nagar Ayurvedic Layout Nagpur Maharashtra
440024
Nagpur
MAHARASHTRA |
9822246598
drdvhange@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Government Ayurved College,Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D758||Other specified diseases of bloodand blood-forming organs. Ayurveda Condition: RAKTAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Month(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Patients having age above 5 months to 25 years of HbSS pattern and patients having age above 5 month to 50 years of HbAS pattern
Patients having classical signs of sickle cell disease
Patients irrespective of Gender,Religion,socioeconomic status will be selected
Co-operative patients |
|
| ExclusionCriteria |
| Details |
Patients is k/c/o Haemophilia,Thalassemia,G6PD
deficiency.
Patients having other types of anemia.
Pregnant women and Lactating mothers.
Non co-operative patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find Nidan Panchak of Sickle Cell Disease as per Ayurved |
Day 1 (one time) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the Upadravas Of Sickle cell disease as per Ayurved |
one time |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In the Present Study total 100 Participants will be taken .Througly physical examination will be done then Hb electrophorerosis will be carried out .It will be helpful to classify the patient into Hb AS and Hb SS pattern as per the clinical symptoms of the patient and Dosh dushya Samurcchana nomenclutare of disease will be given on the basis of predominency of dosha . |