CTRI

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CTRI Number

CTRI/2024/08/072272 [Registered on: 09/08/2024] Trial Registered Prospectively

Last Modified On:

24/07/2024

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

Clinical trial to study the efficacy of Vidangadi Mandura in panduroga with special reference to iron deficiency anaemia between age 6 to 12 years.

Scientific Title of Study

A randomized controlled clinical trial to study the efficacy of Vidangadi Mandura in panduroga with special reference to iron deficiency anaemia in school going children.

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 Shubhangi Rajendra Divekar
Designation	Postgraduate student
Affiliation	SMBT Ayurveda college and Hospital
Address	Department of Kaumarbhritya SMBT Ayurveda college and Hospital,Nandi Hills, Dhamangaon Igatpuri Nashik MAHARASHTRA 422403 India
Phone	09545755494
Fax
Email	shubudivekar2018@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Mayuri Nagre
Designation	Associate Professor
Affiliation	SMBT Ayurveda college and Hospital
Address	Department of Kaumarbhritya SMBT Ayurveda college and Hospital, Nandi Hills, Dhamangaon, Igatpuri, Nashik 422403,Maharashtra,India Nashik MAHARASHTRA 422403 India
Phone	7774056257
Fax
Email	mayurigennext@gmail.com

Details of Contact Person
Public Query

Name	Dr Shubhangi Rajendra Divekar
Designation	Postgraduate student
Affiliation	SMBT Ayurveda college and Hospital
Address	Department of Kaumarbhritya SMBT Ayurveda college and Hospital,Nandi Hills, Dhamangaon Igatpuri MAHARASHTRA 422403 India
Phone	09545755494
Fax
Email	shubudivekar2018@gmail.com

Source of Monetary or Material Support

Department of Kaumarbhritya SMBT Ayurved College and Hospital, Nandi Hills, Dhamangaon,Tal-Igatpuri,Dist- Nashik.Pin-422403,Maharashtra, India

Primary Sponsor

Name	Dr Shubhangi Rajendra Divekar
Address	Department of Kaumarbhritya SMBT Ayurveda college and Hospital,Nandi Hills, Dhamangaon Igatpuri,Nashik-422403,Maharashtra, India
Type of Sponsor	Other [Self Individual.]

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 Shubhangi Rajendra Divekar	SMBT Ayurved College and Hospital	OPD no. 12 Department of Kaumarbhritya SMBT Ayurved College and Hospital Dhamangaon Igatpuri 422403 Maharashtra,India Nashik MAHARASHTRA	09545755494 shubudivekar2018@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SMBT Ayurved College and Hospital	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

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Vidangadi Mandura, Reference: Sharma ,Pranacharya Shrisadanandan ,and Pandit Kashinathshastrina.Rastarangini.10th ed.Motilal Banarasidas,chapter 21th,1979.p 518, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Doses of drugs are given according to age of patient. Max dose-1.25gm,Min dose-1gm
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Darvyadi Leha, Reference: Sharma,Vd.Vijay S. Charaksamhita,1st ed.,vol2nd part,Chaukhamba Sanskrut Prakashan,chikitsasthan16,2013,Pp401,Shlok no 97, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Madhu ,Sarpi), Additional Information: -Doses of drug are given according to age of child. Max dose-1gm ,Min dose -0.75gm

Inclusion Criteria

Age From	6.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	1.Children having haemoglobin 8-11.4gm/dl 2.Patients diagnosed as iron deficiency Anaemia by performing CBC. 3.Patients will be selected irrespective of age, sex, religion, socioeconomic status and food habits, caste.

ExclusionCriteria

Details

1.Anaemia other than Iron deficiency Anaemia

2.Patients requiring hospitalization, blood
transfusion

3.Haemoglobin percentage less than 8gm/dl.

4. Acute bleeding due to recent trauma.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Centralized

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Change in Hb% with sign and symptoms.	30 days

Secondary Outcome

Outcome	TimePoints
Comparison with Trial and control group.	18 Months

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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 3

Date of First Enrollment (India)

13/08/2024

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 Applicable

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

According to NFHS4 prevalence of Iron deficiency anemia in Urban area is 55.9%, Rural is 59.4% & overall is 58.4%. Anaemia has impact on neurological development. Iron Deficiency can hamper both physical and mental development of child.Prominent diagnostic feature of Pandu is pallor on skin which occur due to quantitative and qualitative deficiency of Raktadhatu. Anaemia is well treated by modern drugs but there are many limitations & side-effects such as constipation, nausea, vomitting.

Null hypothesis-Vidangadi Mandura is not effective in Panduroga

Alternative hypothesis_Vidangadi Mandura is effective in Panduroga.

Ayurved samhita has given much good formulations on Pandu. One of these formulations is Vidangadi Mandura. Vidangadi Mandura contains dravyas which are dipana ,pachana, raktavardhak properties. Vidangadi Mandura contains Mandura bhasma which is better in children as compared to Lohbhasma. Conducting Research to evaluate effectiveness of Vidangadi Mandura in Panduroga is crucial for exploring our understandings of traditional remedies and their applications in modern helathcare. By filling knowledge gap study can provide valuable insights into potential benefits of Vidangadi Mandura and its role in managing Pandu. Including patients within school age grouop who fulfill clinical diagnostic criteria for Pandu are selected irrespective of sex, socioeconomic status and community helps in achieving a diverse diverse and representative sample enhancinng the generalizability of study findings. Written consent from parents ensures ethical compliance and transparency in treatments. Total 100 number of patients will be selected and divided into two groups named as Group A (Trial Group) & Group B (Control Group) will be given to the patients. Simple random sampling techniques will be used. Trial and Control drug will be purchased from GMP certified pharmacy. Both drugs will be administered in vati form for 30 days. All SOP of vati form will be strictly given before meal.