| CTRI Number |
CTRI/2025/10/095793 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare Effect Of Navayasa Churna And Dadima Swaras Along With Navayasa Churna In Management Of Panduroga(Anemia). |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Navayasa Churna And Dadima Swaras Along With Navayasa Churna In Management Of Panduroga (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 |
DrMayuri Machhindra Hiwale |
| Designation |
MD Swasthavrittha Scholar |
| Affiliation |
Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule |
| Address |
Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule
Dhule
MAHARASHTRA
424002
India |
| Phone |
8668600941 |
| Fax |
|
| Email |
mayurihiwale68368@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajesh Maganlal Shah |
| Designation |
MD Swasthavrittha |
| Affiliation |
Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule |
| Address |
Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule
Dhule
MAHARASHTRA
424002
India |
| Phone |
9372811149 |
| Fax |
|
| Email |
drrmshah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRajesh Maganlal Shah |
| Designation |
MD Swasthavrittha |
| Affiliation |
Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule |
| Address |
Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule
MAHARASHTRA
424002
India |
| Phone |
9372811149 |
| Fax |
|
| Email |
drrmshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavrittha, Smt K C Ajmera Ayurved Mahavidyalya Deopur, Dhule, Maharashtra, India pin code -424002 |
|
|
Primary Sponsor
|
| Name |
Smt K C Ajmera Ayurved Mahavidyalya Deopur Dhule |
| Address |
Department Of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule, Maharashtra, India pin code -424002 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrMayuri Machhindra Hiwale |
Smt K C Ajmera Ayurved Mahavidyalya And Hospital Deopur, Dhule |
Department of Swasthavrittha Smt K C Ajmera Ayurved Mahavidyalya Dayasagar Educational Campus Deopur, Dhule
Dhule
MAHARASHTRA |
8668600941
mayurihiwale68368@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I998||Other disorder of circulatory system. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1Patient of age group 18 to 50 years irrespective of genderreligions and cast 2 Having signs and symptoms of panduroga without any complication 3 Haemoglobin percentage in between 8 gm/dl to 10 gm/dl |
|
| ExclusionCriteria |
| Details |
1 Patients with Anemia like thalassemia sickle cell anemia leukaemia aplastic anemia anemia to bleeding piles 2 Know case of chronic and acute liver disorder ascites,ccf,ARF,CRF,AIDS,TB,Leprosy,Any Malignancy, Autoimmune Disease, Rheumatoid Arthritis,Rectal Cancer ,Gastric Ulcers,etc 3 Bleeding Disorders like Haematemesis,Malena,Menorrhagia,Metrorrhagia 4 pregnant women and lactating mothers 5 Patients below age 18 year and above 50year group. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Dourbalyata (weakness) decreased
2)Shwasa (difficulty in breathing) decreased
3)Gaurava(heaviness in body) decreased
4)Aruchi(loss of taste) decreased
|
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Panduta (paleness) decreased
2)Hridspandan(palpitations) decreased
3)Pindikodwestna(cramps) decreased |
7 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
23/10/2025 |
| 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="1"
Months="6"
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
|
In Today’s era lot of changes seen like, Life Style, Living Habits, environmental changes due to this people are getting affected to disease because of weak immune system. In this 21 century anemia is the most common disease in general population. It also called as panduroga.Pandu is Pitta Pradhana vyadhi caused by vitiation of all three dosha, it is mainly caused by dietary and behavioral habit that vitiate pitta.due to etiology the potta pradhana tridosha gets vitiated and circulate in whole body causing shithilata in all dhatus and dhatvagni mandya leading to Raktakshaya. As per mention in Charak samhita chikitsastana panduroga is pitta-dominant Tridosha vyadhi in which Alpa Raktata(reduced blood ) or Dushta Rakta (vitiated blood ) is the primary cause pandur (pallor) vivarnata of twaka (skin discoloration). Panduroga correlated to anemia because most of sign and symptoms such as Panduta(paleness),Dourbalyata(weakness),Hridspandan(palpitations), Shwasa(heaviness in breathing), Gaurava ( feeling of heaviness), Aruchi (loss of taste), Pindikodwestana(cramps), Alasya are similar as found in Panduroga. As treatment of Panduroga pitta dosh vyadhi in Charak chikitsastana 16 -Pandurog chikitsa. The acharya says use of navayasa churna in Panduroga chikitsa. In bhavprakash nighantu (Atha aamradi phalavarg 101-104) the acharya says dadima is like lohitpushpak ( red colour flower like) dadima karma was hridya and Raktavardhaka. 1) Null Hypothesis (H0)- There is no significant difference between Navayasa churna and Dadima Swaras Along With Navayasa Churna in Management of Panduroga (Anemia). 2) Alternate Hypothesis(H1) - There is significant difference between Navayasa churna and Dadima Swaras Along with Navayasa churna in Management of Panduroga (Anemia ). |