| CTRI Number |
CTRI/2024/08/072834 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mandukaparni(Gotukola)Powder in Anemia |
|
Scientific Title of Study
|
Effect of Mandukaparni ( Centella asciatica Linn) churna in Pandu w.s.r Iron deficiency Anemia- A Randomized Controlled Clinical Trail |
| 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 Shivaleela Prabhuswamimath |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dept of Swasthavritta KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
7760418257 |
| Fax |
|
| Email |
shivaleela241999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjeev S Tonni |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dept of Swasthavritta KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9448543858 |
| Fax |
|
| Email |
sanjeevtonni@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjeev S Tonni |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dept of Swasthavritta KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA 590003 India |
| Phone |
9448543858 |
| Fax |
|
| Email |
sanjeevtonni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KLE Shri B M Kankanawadi Ayurveda Mahavidyalaya,Shahapur Belagavi Karnataka India
Pincode 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Shivaleela Prabhuswamimath |
| Address |
KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India
Pincode 590003 |
| 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 Shivaleela Prabhuswamimath |
KAHERs Shri BMK Ayurveda Mahavidyalaya Belagavi |
Department of Swasthavritta Swastharakshana OPD
OPD No 2 KLEUs Shri BMK Ayurveda Mahavidyalaya Belagavi Karnataka India
Pincode-590003 Belgaum KARNATAKA |
7760418257
shivaleela241999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee on Human Subjects KAHERs Shri B.M.Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital,Shahapur,Belagavi |
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 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shigru Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mandukaparni Churna, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient not on any Iron supplement medication.
Where Hemoglobin concentration value is moderate 8 g/dl – 10 g/dl
Individuals of either sex between the age group of 20 to 60 years, irrespective of caste and religion and fulfilling diagnostic criteria of moderate Anemia.
Peripheral Smear: Microcytic and hypochromic & normocytic and hypochromic anemia Patients will be selected.
|
|
| ExclusionCriteria |
| Details |
Patient on Iron supplement medication.
Hemoglobin concentration more than 10g/dl and less than 8 g/dl
Subjects with bleeding disorders and hypotensive.
Patients with alcohol dependency or drug dependency.
Pregnant or lactating women.
Patients suffering from major systemic illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Complete blood count
b) Haemoglobin concentration
c) Peripheral smear
d) Serum iron
|
baseline, day 60
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pandutva (Pallor)
Shiroshula (Headache)
Hridspandan (Palpitation)
Brahma (Giddiness)
Rukshata (Dryness) in - Twaka, Nakha, Hastapadatala, Kesha
Shrama (Fatigue)
Shwasa (Dyspnea)
Pindikodweshtanam (Leg Cramps)
Aruchi (Anorexia)
Gaurava (Heaviness)
Akshikuta Shotha (Periorbital Edema)
Daurbalya (General Weakness)
|
baseline, day 30 ,day 60 |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
12/01/2025 |
| 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 Yet Recruiting |
| 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 Ayurveda,
Aahara, Nidra and Brahmacharya
are said to be the three sub-pillars of health. Among them, Aahara is said to be crucial for
maintaining both a healthy body and mind.
Anemia is characterized by diminished
levels of Red blood cells / haemoglobin in the bloodstream , it
is significant Health concern globally in India and it is particularly
prevalent with one of the highest rates reported worldwide. Iron deficiency is
identified as the primary cause of Anemia, leading to condition similar to Pandu, which is Santarpanajanya &
Rasa-pradoshaja Vyadhi
Iron Deficiency Anemia (IDA) is very
common in India and the commonest nutritional deficiency all over the world,
but its Prevalence is higher in developing countries like India. In India the
Prevalence of Anemia is 52%, WHO estimates that nearly 1/3rd of world’s
Population is suffering from Anemia.
The nearest correlation of IDA can be made
with Pandu Roga in Ayurveda. Pandu Roga is a disease entity described in Ayurveda which bears great resemblance to the clinical picture of
Anemia. In modern era, changing lifestyle via Aahara and Vihara has a
significant impact on development of many ailments; Pandu Roga is one of them. It is developed due to impaired
formation of Rasa-Dhatu from Aahara Rasa, which in turn leads to
depletion in Rakta-dhatu. Rasavaha and Raktavaha srotas are most important in the Patho-physiology of Pandu roga.
Systematic monographs of single drugs can
be very useful for clinical application.
Mandukaparni
(Centella asiatica Linn) is a small,
fast-growing perennial herb found throughout India. It is economically
beneficial and abundantly available and is one of the most commonly used green
leafy vegetable in some countries due to its high amount of medically important
triterpenoids & beneficial carotenoids. It is also known to contain Vit-B,
Vit-C, proteins, important minerals and some other phytonutrients such as flavonoids,
volatile oils and polyphenol available. In Ayurveda, Dwadasha Ahara Varga is mentioned and among them Shaaka Varga, many vegetables are
explained and mentioned in managing conditions similar to Pandu, among them Mandukaparni
(Centella asiatica Linn) is one
of the potential vegetable. Properties
of Mandukaparni includes Tikta and Kashaya rasa, Laghu guna, Sheeta veerya, Tridosha-shamaka property
and Panduhara action these suggest potential efficacy in preventive & managing Anemia.
The best preparation used in modern
science is Ferrous Sulphate 100 mg twice a day, but this has adverse effect
related to Gastro intestine, hence a novel approach for the
management of Pandu roga without
using Iron in any form is taken in this particular research study. Mandukaparni in Churna form can be used as a substitute for iron tablets in people
suffering from Iron Deficiency Anemia. Keeping all these issues in the mind,
present study has been planned to popularize and promote the Mandukaparni in daily intake and to
assess the effectiveness of Mandukaparni Churna
in adult anemic population. |