| CTRI Number |
CTRI/2026/04/107797 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the comparative effect of darvyadi loha and navayas loha in the management of pandu w.s.r to iron deficiency anaemia. |
|
Scientific Title of Study
|
A RANDOMISED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF
DARVYADI LOHA AND NAVAYAS LOHA IN MANAGEMENT OF PANDU W.S.R. TO IRON DEFICIENCY ANAEMIA. |
| 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 Nikita jain |
| Designation |
PG SCHOLAR |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD no 2,3,10 kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar
chawdi, solapur, MAHARASHTRA 413002 India
Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
07758059904 |
| Fax |
|
| Email |
nikita.jain@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Channamma Hiremath |
| Designation |
Associate Professor, kayachikitsa department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD no 2,3,10 kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India
Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
07758059904 |
| Fax |
|
| Email |
channamma.hiremath@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita jain |
| Designation |
PG SCHOLAR |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD no 2,3,10 kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India
Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India
Solapur
MAHARASHTRA
413002
India |
| Phone |
07758059904 |
| Fax |
|
| Email |
nikita.jain@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA 413002 India |
|
|
Primary Sponsor
|
| Name |
Dr Nikita jain |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119
shukrawar peth, near juni faujdar chawdi, solapur, MAHARASHTRA
413002 India |
| 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 Nikita jain |
Seth Sakharam Nemchand Jain C chawdi, solapur, MAHARASHTRA 413002 India |
OPD 3,2 kaychikitsa department,Seth Sakharam Nemchand Jain Ayurved Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi,solapur,MAHARASHTRA 413002 India Solapur,MAHARASHTRA
Solapur
MAHARASHTRA |
7758059904
nikita.jain@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Govindji Raoji Ayurved Mahavidhyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I00-I99||Diseases of the circulatory system. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navayas Loha, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu and ghrit), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi Loha, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu and ghrit), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants with classical signs and symptoms of Pandu Roga
2) Participants between age group of 19- 59 yrs irrespective of, religion,socioeconomic
status, occupation, marital status
3) Patients having Hb% - A) 7 to 11 gm/dl in females B) 7 to 12 gm/ dl in males
4) Patients willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
1) Anaemia during pregnancy
2) Patients present with known case of any bleeding disorders, Thrombocytopenia,
Hemorrhoids
3) Patients having anaemia with known case of any chronic illness and Systemic
disorders like DM, CKD
4) Anaemia other than iron deficiency anaemia
5) Patient with H/O chronic Iron Deficiency Anaemia |
|
|
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 |
1) To evaluate the efficacy of darvyadi loha in pandu vyadhi
2)To investigate the impact of darvyadi loha on biochemical marker by analysing the differences in laboratory findings, pre and post treatment |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To review literature about Pandu roga with reference to iron deficiency
Anaemia from various Ayurvedic Samhita’s and modern medicine books
respectively.
2. To study detailed samprapti of Pandu vyadhi. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/04/2026 |
| 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="5"
Days="29" |
|
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 todays Era, irrelevant dietary habits and changed Lifestyle of Mankind, Humans are too much prone to various nutritional deficiency diseases. Panduroga is one of disease among such disorders.Pandu widely described in various vedas and ayurvedic texts as an independent disaease or associated symptoms of other disease. People eating fast junk, oily unhealthy food in which essential nutrients are absent. Due to these reasons nutritional deficiency occure. In Modern system of medicine, Clinical features of Iron Deficency Anaemia resembles with the Panduroga. Iron deficiency anaemia is one of the common deficiency disease. In anaemia haemoglobin concentration falls below the accepted range depending upon age and gender. There are several types of anaemia amongst them iron deficiency anaemia is very common. Due to less dietary intake, poor availability of iron, chronic blood loss, its prevalence is high. In Charak Samhita, Acharya Charaka has Explained the Pandu roga in Chikitsa sthan and also explains in sutrasthan as santarpanjanya vyadhi, where as in Sushrut Samhita Acharya Sushruta has described it under the uttartantra Panduroga pratishedhadyaya while in Ashtanga Hridya, Acharya Vagbhata described Panduroga in Chikitsasthan with Panduroga chikitsa adhaya.Orally iron supplements are used. The drugs have multiple side effects like nausea, vomiting, epigastric pain, diarrhoea, heart burn etc. Even they are very costly and not affordable at all. Ayurveda has explained Panduroga in detail with its type, causes, symptoms and different aspects of treatment including shodhana, shamana, with various drug formulations and without side effects also they are economically affordable. Keeping all these factors in mind. Ayurvedic treatment for this disease may be more effective than modern medicine. Charak samhita described “Darvyadi Loha” in the management of Pandu roga ,which has the property of Pitta shamana. The ingredients of Darvyadi Loha are easily available and affordable. Taking all these factors into consideration Darvyadi Loha has been selected as drug of choice and Navayas Loha as control drug in management of pandu roga. The study will be conducted for 30 days ,having follow up on 0th,15th and 30th day. Darvyadi Loha and Navayas Loha will be given for 30 days after food with madhu and ghrit. Before and after treatment assesment will be done with help of symptom relief. |