| CTRI Number |
CTRI/2025/03/081867 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Siddhar Yogam and karisalai legium for Iron deficiency Anaemia |
|
Scientific Title of Study
|
Evaluation of therapeutic effect of Siddhar Yogam and Karisalai legium in the management of Azhal veluppu noi (Iron Deficiency Anaemia) in patients reporting at Ayothidoss Pandithar Hospital National Institute of Siddha- A randomized triple arm single centric comparative clinical 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 |
NAVEENA E |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Siddhar Yoga Maruthuvam, Room no 13, Ayothidoss Pandithar Hospital, National Institute of Siddha,Tambaram sanatorium, Chennai-47, Tamilnadu, India.
Chennai
TAMIL NADU
600047
India |
| Phone |
9443801962 |
| Fax |
|
| Email |
naveenaekambaram0589@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVMahalakshmi |
| Designation |
professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Siddhar Yoga Maruthuvam, Room no 13, Ayothidoss Pandithar Hospital, National Institute of Siddha,Tambaram sanatorium, Chennai-47, Tamilnadu, India
Chennai
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVMahalakshmi |
| Designation |
professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Siddhar Yoga Maruthuvam, Room no 13, Ayothidoss Pandithar Hospital, National Institute of Siddha,Tambaram sanatorium, Chennai-47, Tamilnadu, India
Chennai
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha,Tambaram sanatorium, Chennai-47. |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram sanatorium, Chennai-47 |
| Type of Sponsor |
Government medical 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 Naveena E |
Ayothidoss Pandithar Hospital |
Department of Siddhar Yoga Maruthuvam, op no 13,National Institute of Siddha,Tambaram sanatorium,Chennai-47
Chennai
TAMIL NADU |
9443801962
naveenaekambaram0589@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Internal medicine |
Karisalai legium
Dosage:5g twice a day after food
Duration:48 days |
| Comparator Agent |
No comparator agent |
NIL |
| Intervention |
Siddhar Yogam |
Relaxation techniques
Tirikonasanam Vajrasanam
Bhavana mukthasanam Puyangasanam Paschimothasanam
Machrasanam Savasanam
Nadi suthi pranayamam Dhiyanam 30-35 minutes twice a day in an empty stomach Duration-48 days |
| Intervention |
Siddhar Yogam and internal medicine |
Relaxation techniques Tirikonasanam Vajrasanam Bhavana mukthasanam Puyangasanam Paschimothasanam Machrasanam Savasanam Nadi suthi pranayamam Dhiyanam 30-35 minutes twice a day in an empty stomach Duration-48 days
along with Karisalai legium Dosage:5g twice a day after food Duration:48 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Hb level less than normal range (According to WHO criteria) For male:9-12gm/dl(Normal:13gm/dl)For female:8-11 gm/dl(Normal:12gm/dl)
Blood smear shows microcytic hypochromic anaemia |
|
| ExclusionCriteria |
| Details |
Patients with chronic diseases
Patients with positive Faecal occult blood and haematochezia
H/o Inherited blood disorders(Sickle cell anaemia, Thalassemia)
H/o Cardiac disorders, colorectal cancer, haemorrhoids
H/o Spinal deformities (Scoliosis,kyphosis)
H/o Tuberculosis and other infections in the spine(abscess,meningitis,vertebral osteomyelitis)
Abnormal reading of lung capacity excluded using lung spirometry test
pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the study will be assessed by increase in haemoglobin level after treatment |
Screening - 6 months
Patient enrollment - 6 months
Data analysis - 1 month
Follow up - 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/03/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Anaemia is a major public health problem in the world. Around 30% of the total world population is anaemic. It is defined as reduction of RBC volume or Hb level below the normal range ,characterized by lassitude, fatigue, breathlessness, palpitation, pallor of skin and mucous membrane. Its due to a low level of circulating red blood cells (RBC’s) ,which reduces their capacity to carry oxygen in the body. According to siddha literature , it may be correlated to Azhal veluppu noi. Veluppu noi is described as a diseased condition in which nature of the body including nail beds and conjunctiva becomes pallor. Hence, considerably more patients of Iron deficiency anaemia (Azhal veluppu noi) have been recorded in the Ayothidoss Pandithar Hospital. The siddha drug Karisalai legium is said to be cost effective and has Anti oxidant and hepatoprotective properties. Siddhar yogam practice may help in the production of haemoglobin and necessary elements in the blood in the pure form. Various techniques in yoga has been previously documented in the increase of Hb level. So, I hope Karisalai legium and Siddhar yogam will be effective in the treatment of Azhal veluppu noi (Iron Deficiency Anaemia). |