| CTRI Number |
CTRI/2024/07/070273 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect of Ellum tippalyadi Lehya in patients with Iron Deficiency Anemia |
|
Scientific Title of Study
|
Effect of Ellum Tippalyadi Lehya in Iron Deficiency Anemia |
| 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 N Srilakshmi |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda college Tripunithuru |
| Address |
Department of Rasashastra and Bhaisajya Kalpana Government Ayurveda college and Hospital,
puthiyakavu, Dhanwantari Nagar, Tripunithura- 682301, Ernakulam, Kerala, INDIA.
Ernakulam
KERALA
682301
India |
| Phone |
9633621894 |
| Fax |
|
| Email |
dr.srilakshmin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh V |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda college Tripunithuru |
| Address |
Department of Rasashastra and Bhaisajya Kalpana Government Ayurveda college and Hospital,
puthiyakavu, Dhanwantari Nagar, Tripunithura- 682301, Ernakulam, Kerala, INDIA.
Ernakulam
KERALA
682301
India |
| Phone |
9495218031 |
| Fax |
|
| Email |
dr.rajeshvay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh V |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda college Tripunithuru |
| Address |
Department of Rasashastra and Bhaisajya Kalpana Government Ayurveda college and Hospital,
puthiyakavu, Dhanwantari Nagar, Tripunithura- 682301, Ernakulam, Kerala, INDIA.
KERALA
682301
India |
| Phone |
9495218031 |
| Fax |
|
| Email |
dr.rajeshvay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital Tripunithura
Ernakulam, Kerala -682301
India |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College and Hospital Tripunithura |
| Address |
Department of Rasashastra and Bhaisajya Kalpana Government Ayurveda college and Hospital,
puthiyakavu, Dhanwantari Nagar, Tripunithura- 682301, Ernakulam, Kerala, INDIA. |
| Type of Sponsor |
Other [Government Ayurveda College] |
|
|
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 N Srilakshmi |
Government Ayurveda College and Hospital Tripunithura |
Department of Rasashastra and Bhaisajya Kalpana Government Ayurveda college and Hospital,
puthiyakavu, Dhanwantari Nagar, Tripunithura- 682301, Ernakulam, Kerala, INDIA.
Ernakulam
KERALA |
09633621894
drsrilakshmin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH Govt Ayurveda College Tripunithura Kochi Kerala |
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: Ellum Tippalyadi Lehya, Reference: Sahasrayogam Lehya Prakarana Yoga no 8 (Chaukhambha Sanskrit Series Office, Varanasi) , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants between 18 to 60 years of age irrespective of sex having Serum Haemoglobin level less than 12gm/dl in females and below 13gms/dl in males
|
|
| ExclusionCriteria |
| Details |
Participants with Haemoglobin less than 7gm/dl
Participants with Anemia of other Known Cause
Participants with Diagnosed Renal, Hepatic, Cardiac Diseases
Participants Suffering from Cancer or Other Life-threatening Diseases
Participants having severe Blood loss conditions like Heavy Menstruation and Bleeding Piles
Pregnant And Lactating Women
Participants who are taking any other iron Supplements
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Serum Haemoglobin Level of Participants |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Severity of Subjective Criteria such as Pallor, Weakness, Fatigue, Anorexia, Irritability, Dyspnea, Palpitations |
30 days |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
04/09/2024 |
| 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
|
Iron deficiency anemia is the most prevalent form of anemia in the society. Iron deficiency
occurs primarily due to poor dietary intake of iron and also its poor absorption from intestine. Severe
blood loss, as in heavy menstruation, bleeding piles and other hemorrhagic diseases is also a major
etiological factor for this disease. Ayurveda correlates iron deficiency anemia to Pandu. A wide range
of formulations, both herbal and herbo mineral are explained in Ayurveda Samhitas for its management.
Ellum tippalyadi lehya is one such formulation, mentioned in Sahasrayoga. Basically, it is a lohakalpa
in avaleha form. It contains Tila, Pippali, Badara, Lohabhasma, Makshika bhasma, and Shundi and is
indicated in Arshas, Pleeha, Pandu etc. The primary treatment for iron deficiency in conventional med icine is oral supplementation of iron compounds like ferrous fumarate,ferrous gluconate, ferrous sul phate etc. But these are often associated with gastric discomforts like nausea vomiting, constipation or
diarrhea, flatulence, metallic taste, staining of teeth or epigastric distress. Ellumtippalyadi lehya can be
effective in iron deficiency anemia owing to the properties of its ingredients, which improves digestion,
reduces the gastric discomforts and also helps in better absorption of iron. A study will be conducted
among people of 18 to 60 years of age to evaluate the effect of Ellum tippalyadi lehya in reducing the
symptoms of iron deficiency anemia. The type of study is single group pre and post interventional.
Participants satisfying the inclusion and exclusion criteria will be selected from the OPD of Government
Ayurveda college Hospital, Tripunithura. Assessment will be done before and after the treatment. Re sults will be analysed statistically. The data obtained before treatment on 0th day and after the treatment
on the 31st day will be used for statistical analysis.
|