| CTRI Number |
CTRI/2020/10/028715 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
21/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study Of Guda Nagaradi Gutika And Dhatri Lauha In Pandu Vyadhi. |
|
Scientific Title of Study
|
Comparative Clinical Study To Evaluate Efficacy Of Guda Nagaradi Gutika And Dhatri Lauha In Pandu Vyadhi. |
| Trial Acronym |
GNGIPV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijeet Chavan |
| Designation |
Medicine Resident |
| Affiliation |
Sumatibhai shah Ayurved Mahavidyalay |
| Address |
OPD NO 2 Kayachikitsa Department First Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Sumatibhai shah Ayurved College and Hospital Hadpsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9309913876 |
| Fax |
|
| Email |
chavanabhijeet5011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree N Tongaonkar |
| Designation |
Professor |
| Affiliation |
Sumatibhai shah Ayurved Mahavidyalaya |
| Address |
OPD NO 2 Kayachikitsa Department First Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Sumatibhai shah Ayurved College and Hospital Hadpsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9822829493 |
| Fax |
|
| Email |
jntayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhijeet Chavan |
| Designation |
Medicine Resident |
| Affiliation |
Sumatibhai shah Ayurved Mahavidyalay |
| Address |
OPD NO 2 Kayachikitsa Department First Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Sumatibhai shah Ayurved College and Hospital Hadpsar Pune 28
Pune
MAHARASHTRA
411028
India |
| Phone |
9309913876 |
| Fax |
|
| Email |
chavanabhijeet5011@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai shah Ayurved Mahavidyalaya OPD NO 2 Kayachikitsa Department First Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Type of Sponsor |
Private 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 Abhijeet Chavan |
Sane Guruji Arogya Kendra |
Sane Guruji Arogya Kendra Malwadi Hadpsar pune 28
Pune
MAHARASHTRA |
9309913876
chavanabhijeet5011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dhatri Lauha |
Orally 500 mg BD with 5ml Goghrit for 45 days |
| Intervention |
Guda Nagaradi Gutika |
Orally 500 mg BD with 5ml Goghrit for 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Pandu vyadhi will be diagnosed on the basis of cardinal symptoms of pandu vyadhi (Panduta,Dourbalya,Agnimandya,Akshikuta Shotha,Hritspandan) and Hemogram.
2) Hb % more than 8 gm% and less than normal. i.e Male <13g/dl and Female <12g/dl.
3)MCV less than normal.[80-100fl]
4) Irrespective of gender,religion,socio-economic status,marital status |
|
| ExclusionCriteria |
| Details |
1) Known case of Endocrine disorder like Diabetes mellitus,hypothyroidism,cushing syndrome etc.
2) Pregnant and lactating lady.
3) Patient having tuberculosis, known case of HIV, leprosy any type cancer.
4) Patient showing signs and symptoms of internal bleeding hemorrhoids menprrhagia etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Guda Nagaradi gutika in pandu vyadhi with special reference to iron deficiency anemia by clinical and biochemical( Hemogram, Sr.Iron) parameters. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare the efficacy of Guda Nagaradi gutika and Dhatri Lauha in pandu vyadhi with special reference to iron deficiency anemia on the basis of change in hemogram and Sr.Iron.
2)To compare the efficacy of Guda Nagaradi gutika and Dhatri Lauha in pandu vyadhi with special reference to iron deficiency anemia on the basis of subjective parameters(Panduta,Dourbalya,Akshikut Shotha,Hritspandan). |
45 days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 1 |
|
Date of First Enrollment (India)
|
01/11/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary : To assess the efficacy of ‘Guda Nagaradi Gutika’ in ‘Pandu vyadhi’ with special reference to iron deficiency anemia by clinical and biochemical (Haemogram ,
Serum Iron) parameters.
.Selection of topic : This study is planned to assess the efficacy of Guda Nagaradi Gutika in ‘Pandu vyadhi and to provide better option for its
management. In today’s changing world, “The poor are not able to afford a
good diet, and the rich due to their fondness for junk food, do not eat a balanced
diet.†Thus, malnutrition either due to inadequate dietary intake or lack of
balanced diet and population explosion has lead to the development of various
diseases, Pandu Roga is one of such disease. On the basis
of similarity between symptoms, Pandu Vyadhi can be correlated with Anemia.
Iron deficiency Anemia is thought to be most common cause of Anemia globally.
Iron deficiency anemia is very common condition having various causes like
impairment in RBCs production, nutritional deficiency and systemic disorders in
developing countries.Side effects of oral allopathic iron preparations are constipation, abdomen
discomfort, heart burn, epigastric pain, nausea, vomiting etc. Therefore, to get a
better alternative medicine this topic is selected.
Gudanagaradi Gutika contains Guda, Nagar, Mandur, Til and Pippali.
It is useful in treating Pandu Vyadhi as suggested by Charak acharya of ayurveda by its Rasayana,
Deepana & Pachana, Raktvardhak, Raktshodhak property and to find out cost
effective treatment . Hence, this subject is considering for study, to assess the
efficacy of Guda Nagaradi Gutika in ‘Pandu vyadhi .
considering all the above things the study will be carried out in comparison
between two ayurvedic formulations. Patients will be divided into 2 groups
containing 33 each. 1 group will be given Guda Nagaradi Gutika and other
group will be given Dhatri Lauha. On 1st day And 45th day
Serum Iron and Haemogram will be carried out. Results and conclusion will be drawn from the
observations made during the study. |