CTRI Number |
CTRI/2021/01/030510 [Registered on: 15/01/2021] Trial Registered Prospectively |
Last Modified On: |
15/01/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Management of Anemia with Sammoha loha |
Scientific Title of Study
|
A STANDARD COMPARATIVE CLINICAL STUDY ON PANDUROGA W.S.R. TO IRON DEFICINCEY ANEMIA WITH SAMMOHA LOHA OVER FERROUS SULPHATE |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rajeshwari M S |
Designation |
PG Scholar |
Affiliation |
DGM Ayurvedic Medical College |
Address |
Department of Kayachikitsa, Division G1, Room No 3.
DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag
Gadag KARNATAKA 582103 India |
Phone |
9632036382 |
Fax |
|
Email |
msrajeshwari312@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR R V Shettar |
Designation |
Professor |
Affiliation |
DGM Ayurvedic Medical College |
Address |
Department of Kayachikitsa
DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag Gadag KARNATAKA 582103 India |
Phone |
9845613116 |
Fax |
|
Email |
shettar_dr@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Rajeshwari M S |
Designation |
PG Scholar |
Affiliation |
DGM Ayurvedic Medical College |
Address |
Department of Kayachikitsa, Divisipon G1, Room 3.
DGM Ayurvedia Medical college and hospital Post Graduate Studies and Research Center Gadag
Gadag KARNATAKA 582103 India |
Phone |
9632036382 |
Fax |
|
Email |
msrajeshwari312@gmail.com |
|
Source of Monetary or Material Support
|
DGM Ayurvedic Medical College, Hospital and Research center. |
|
Primary Sponsor
|
Name |
nil |
Address |
Nil |
Type of Sponsor |
Other [Nil] |
|
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 Rajeshawri M S |
DGM Ayurvedic Medical College. Gadag |
Department of Kayachikitsa, Division G1, Room No 3. Gadag KARNATAKA |
9632036382
msrajeshwari312@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:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Ferrous sulphate. |
Dose - 150 mg
frequency - Three times a day after food
Anupana - jala
duration - 30 days |
Intervention |
Sammoha Loha |
Dose - 250 mg
Frequency - Three times a day after food
Anupana - sukoshna jala.
Duration - 30 days |
|
Inclusion Criteria
|
Age From |
10.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patient with symptoms of Panduta, Shrama, Bhrama, Arohana ayasa, Dourbalya, Aruchi, Pindkodwestana, Shoonakshi Koota Shota and Gatrashoola.
1. Patients of Panduroga between the age group of 10 – 60 years.
2. Hb% between 6 gm/dl - 10gm/dl. |
|
ExclusionCriteria |
Details |
1. Known cases of Thalassemia, Sickle Cell Anemia, Pernicious Anemia.
2. Anemia associated with any malignancy.
3. Patients under chemotherapy and radiation treatment etc.
4. Patients suffering from DM and HTN.
5. Anemia due to hookworm infestation. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in subjective parameters and increase in objective parameters |
in 2 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Increase in hemoglobin range and serum ferritin. Reduction in subjective parameters Panduta, Shrama, Bhrama, Arohana ayasa, Dourbalya, Aruchi, Pindakodwestana, Shoonakshi koota, Gatra shoola. |
in 2 months |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
16/01/2021 |
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="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
purpose of study : “A STANDARD COMPARATIVE CLINICAL STUDY ON PANDUROGA W.S.R. TO IRON DEFICINCEY ANEMIA WITH SAMMOHA LOHA OVER FERROUS SULPHATE†Need for the study : Anemia is the most common and intractable nutritional problem in the world today. WHO has estimated that around 2 billion people across the world is suffering from Anemia. Anemia due to iron deficiency is the most prevalent type of Anemia. Iron Deficiency Anemia is one of the most prevalent forms of malnutrition. Globally, 50% of Anemia is attributable to iron deficiency and accounts for approximately 841,000 deaths annually worldwide. Africa and parts of Asia bears 71% of global mortality burden. The majority of iron deficiency is seen in growing children, adolescents, menstruating women, pregnant women and due to inadequate dietary intake of iron. As the name denotes the main feature of Panduroga is pandutva. Panduroga as mentioned in classics is a Pitta Pradana Vyadhi. According to Charaka it is one among the Rasavaha Srotodusti. Here there is Raktha Kshaya due to Pitta which reduces the Raktha Poshakamsha of Rasa. The signs and symptoms of Panduroga include Panduta, Shrama, Bhrama, etc. This description avails the correlation of Panduroga with Anemia in modern science. Iron deficiency Anemia is a disease that has similar symptoms Paleness, Weakness, Fatigue, constitutional symptoms, etiology and pathogenesis. Panduroga and Iron Deficiency Anemia have been studied in parallel to facilitate a better understanding of the disease and to devise a better management. This disease was chosen for the study due to its high incidence. Despite of many programs conducted by various organization and many medicines available for treating Anemia, it still remains as a burning nutritional problem. Oral iron salts are the most readily available way of replacing iron, ferrous sulphate is most effective and economical oral preparation. But about 10 – 20% patients will develop gastrointestinal side effects related to the ferrous sulphate these range from nausea, epigastric discomfort, vomiting, constipation and diarrhoea. Hence an attempt is made to compare the effect of Sammoha Loha over Ferrous Sulphate. With the reference of Rasendra Sara Sangraha Sammoha Loha is chosen for the present study. This is indicated in Panduroga and it contains drugs like Pippali, Maricha, Shunti, Chitraka, Amalaki, Vibhitaki, Hritaki, Vidanga, Lohabhasma, Abhrakabhasma and Ghrita. This has properties like bala, varna, agni vardhana, kamala, pandu rogahara, hridroga, shotahara, krimighna, hence the drug is chosen for the trial. Ferrous sulphate is taken as a standard drug for the comparison. Hypothesis :H0 - Sammoha Loha is not effective in Panduroga. H1 – Ferrous Sulphate is more effective in Panduroga than Sammoha Loha. H2 – Sammoha Loha is more effective in Panduroga than Ferrous Sulphate. |