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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  
Name  Address 
NIL  Nil 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther 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: -
2Intervention ArmDrugClassical(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.

 
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