| CTRI Number |
CTRI/2022/11/047625 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare effect of Indrashani Choorna and Ferrous sulphate in patients having iron deficiency in blood sample. |
|
Scientific Title of Study
|
Comparative controlled clinical study to evaluate efficacy of Indrashani Choorna and ferrous sulphate in
Pandu Vyadhi with special reference to iron deficiency anemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritesh Damle |
| Designation |
Ph.D. scholar |
| Affiliation |
M.A.M.s Sane guruji Arogya Kendra |
| Address |
M.A.M.s Sane guruji Arogya Kendra,Department of Kayachikitsa, OPD no.2, Ground floor, Malvadi, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9423569242 |
| Fax |
|
| Email |
rritesh126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dnyaneshwar Padavi |
| Designation |
Ph.D. Guide |
| Affiliation |
School of Ayurveda, D.Y. Patil deemed to be university, Navi Mumbai |
| Address |
Dr. D.Y. Patil deemed to be university, Sector-7, Nerul, Navi Mumbai, Maharashtra
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9833158688 |
| Fax |
|
| Email |
dmpadavi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritesh Damle |
| Designation |
Ph.D. scholar |
| Affiliation |
M.A.M.s Sane guruji Arogya Kendra |
| Address |
M.A.M.s Sane guruji Arogya Kendra,Department of Kayachikitsa, OPD no.2, Ground floor, Malvadi, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9423569242 |
| Fax |
|
| Email |
rritesh126@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A.M.s Sane guruji Arogya Kendra,Department of Kayachikitsa, OPD no.2, Ground floor, Malvadi, Hadapsar, Pune, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Ritesh D Damle |
| Address |
Sane Guruji Arogya Kendra, ground floor, OPD no.2 Hadapsar, Malvadi, Pune, Maharashtra 411028 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritesh D Damle |
Hospital of School of Ayurved |
OPD and IPD of Kayachikitsa department, 2nd floor, School of Ayurveda, Dr. D.y. Patil deemed to be university, Sector-7, Navi Mumbai 400706
Mumbai (Suburban)
MAHARASHTRA |
9423569242
rritesh126@gmail.com |
| Dr Ritesh D Damle |
Sane Guruji Arogya Kendra |
OPD no-2 and IPD of Department of Kayachikitsa, ground floor, Sane Guruji Arogya Kendra, Malvadi, Hadapsar, Pune.411028
Pune
MAHARASHTRA |
9423569242
rritesh126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
| Institutional ethics committee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Indrashani Choorna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous Sulphate | Dose- 100mg
Frequency - Bid
Anupana - water
Duration - 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) “Pandu Vyadhi†will be diagnosed on the basis of symptoms of Pandu Vyadhi.
2) Age: 18-60 Yrs. Irrespective of gender, religion, Socio - economic status, marital status.
3) Hb % more than 7 gm% & less than normal i.e. Male -< 13g / dl. And female -<12g/dl.
4) MCV less than normal. [80 - 100 fl].
5) PBS – Microcytic hypochromic (morphology)
6)Sr. Iron: below 70 mcg |
|
| ExclusionCriteria |
| Details |
1) Known case of Endocrine disorders like Diabetes mellitus, hypothyroidism, Cushing
syndrome, etc.
2) Pregnant and lactating lady.
3) Patient having Tuberculosis, known case of HIV, leprosy, any type of cancer.
4) Patient showing signs and symptoms of internal bleeding Haemorrhoids, menorrhagia etc. |
|
|
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 |
To observe the changes in signs and symptoms of Pandu with use of Indrashani
Choorna while comparing with ferrous sulphate. |
At Day 0, Day 15th, Day 30th, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the changes in biochemical parameters in patients of Pandu Vyadhi with
the use of Indrasani Choorna while comparing with ferrous sulphate. (Hb, MCV,
MCHC, PBS, Sr. iron)
|
Day 0, Day 45th |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
For the present study, Indrashani Choorna mentioned in Choorna chapter of
Sahasrayoga, has been selected, which comprises of Tila, Pippali, Badara, Madhu, Makshika,
Ayas, Shunthi and Sita. The research hypothesis is that, Indrashani choorna is helpful in the
management of Panduroga with special reference to Iron deficiency Anaemia.
Expected outcome:
• Significant improvement in subjective and objective parameters is expected in this
comparative clinical study.
• Jujube (Badara) was reported to contain numerous minerals. About 0.48 mg iron and
69 mg vitamin C per 100 g of fresh fruit were reported. Being intrinsically rich in
potassium, phosphorus, manganese, iron, zinc these minerals help in maintaining
cardiac health. Jujube is a great way to pump iron reserves, improve hemoglobin count
and regulate thus, the daily intake of jujube could increase our dietary iron and vitamin,
as to prevent anemia due to deficiency of iron or vitamin C.
Hence, Indrashani choorna is expected to increase Hemoglobin level, significantly.
• Since, Indrashani choorna is combination of indigenous compound drug, it is expected
to get well tolerated and clinically safe and better alternative for ferrous sulphate which
is having much adverse effect in management of IDA.
|