| CTRI Number |
CTRI/2024/09/073583 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| 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 study the effect of Ayurvedic drug Panchatikta ghrita guggulu in old age patients of anaemia |
|
Scientific Title of Study
|
Efficacy of PANCHATIKTA GHRITA GUGGULU in the Management of PANDU W.S.R to Iron Deficiency Anemia in Geriatric Patients – A Randomised Control Trial |
| 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 Vaishnavi G kulkarni |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagav |
| Address |
Department of Kayachikitsa-Rasayana evam Vajikarana, KAHERs
Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur,
Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
7019912993 |
| Fax |
|
| Email |
gkulkarnivaish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashavva V Hiremath |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagav |
| Address |
Department of Kayachikitsa-Rasayana evam Vajikarana, KAHERs
Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur,
Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9448945687 |
| Fax |
|
| Email |
drkvhiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashavva V Hiremath |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagav |
| Address |
Department of Kayachikitsa-Rasayana evam Vajikarana, KAHERs
Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur,
Belagavi, Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9448945687 |
| Fax |
|
| Email |
drkvhiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 59003 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi G Kulkarni |
| Address |
Department of Kayachikitsa-Rasayana evam Vajikarana, KAHERs Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahpur Belagavi Karnataka India 590003
Shri B M Kankanawadi Ayurveda Mahavidyalaya, Shahapur,
Belagavi, Karnataka |
| 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 Vaishnavi G Kulkarni |
KLE Ayurveda Hospital and PG Research Centre |
OPD NO-21,6,7 AND IPD wards OF KLE Ayurveda Hospital and PG Research Centre Shahapur, Belagavi
590003, Karnataka
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
7019912993
gkulkarnivaish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
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 | Classical | | (1) Medicine Name: Punarnava Mandura, Reference: Charaka samhita Chikitsa sthana 16/93-96, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -500 mg tablets twice a day for 60 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchatikta Ghrita Guggulu, Reference: Bhaishjya Ratnavali 54/233-236 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 625(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -625 mg 2 tablets thrice a day after food for 60 days |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex of aged more than 60 years
patients with haemoglobin level of 8 gm /dl to 10 gm/dl
serum iron level of less than 60 mcg /dl |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled Diabetes,Hypertension,endocrine dysfunction.
patients of known cases of malignancy condition,post surgical anaemic conditions
patients of known case of Chronic infections like tuberculosis,hepatatis,leprosy,chronic renal disorders
patients with bleeding disorders,conditions of thalassemia,sideroblastic anaemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
haemoglobin levels
serum iron levels |
at baseline and on 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
subjective parameters-panduta,hridspandana,daurbalya,shrama,arohansya shrama
WHO-QOL-BREF |
on baselline,15th,30th,45th,60th day |
subjective parameters-panduta,hridspandana,daurbalya,shrama,arohansya shrama
WHO-QOL-BREF |
on baselline,15th,30th,45th,60th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/01/2025 |
| Date of Study Completion (India) |
10/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Iron deficiency anaemia is one among the commonest types of anaemia also affecting the geriatric population with prevalence of 23% globally and 45% in India. Anaemia is common in old age and increases the risk of physical disability, associated with impaired performance and muscle weakness and has been shown to affect older person’s physical function.Anaemia should not be accepted as an inevitable consequence of aging.[2] The potential negative impact of a low haemoglobin (Hb) level on performance status, physiology, and functional independence appear to be highest in elderly patients. WHO classifies geriatric people with age group of 65-75 as old age,75-85 as advanced old age ,>85 as very advanced old age and it is estimated that there will be 10% increased incidence of iron deficiency anaemia in old age group of 65 years and up to 50% increased risk in age group of >80 years[2].Aging and IDA are directly proportional to each other as there is decreased absorption and assimilation of iron, decreased dietary iron intake, decreased Erythropoeitin sufficiency which brings lot of changes at the cellular levels during erythropoiesis which results in decreased incorporation of iron in red blood cells.The conventional system of medicine uses Iron formulations which are having iron salts such as ferrous sulphate ,ferrous fumarate, iron dextan,ferrous calcium citrate, ferrous succinate etc .long term use of these drugs are reported with nausea, heartburn, constipation, gastric discomfort etc. In a meta analysis comparison of oral and intravenous Iron supplementation shows, that adverse events were reported in 32% of oral supplementation ,and proves the intolerance of oral iron supplementation. Acharya Sushruta opines that there is a decline of Sarva Dhatu (tissue), Indriya (sensory-motor system), Bala (strength), Virya (virility) after Sampurnavastha. Acharya Charaka also considered “hriahyamana Dhatu Guna†(successive decrease in the qualities of Dhatu). Thus, it is clear from the Charaka’s view that both qualitative and quantitative decrease in Dhatu occurs during old age. Bhela Samhita throws further light in this regard. In old age, the capacity for digestion and assimilation (nutrients into Dhatu) is hampered due to Kshaya of Dhatu. Therefore, the replacement of Dhatu is also reduced as a result of already existing vitiation. Panchatikta ghrita guggulu is one of the classical formulation which is commonly used to manage different shula pradhana vata vyadhis,also indicated in the management of Pandu by Bhaisajya Ratnavali.The predominant tikta rasa of Panchatikta ghrita guggulu can act as Raktashodhaka and also can supplement nourishment to asthi,majja dhatus aiding in proper erythropoiesis.[12] So to establish these benefits of Panchatikta ghrita guggulu in pandu this study has been planned. |