| CTRI Number |
CTRI/2024/06/068844 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the efficacy of Suvarnaprashan yoga and Samangadi leha 0n growth and development in Infants |
|
Scientific Title of Study
|
An experimental and randomized clinical study to evaluate the comparative efficacy of Suvarnaprashan yoga and Samangadi Leha on growth and development in Infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Minakshi |
| Designation |
Professor |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh |
| Address |
Room no-218,Anatomy block RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh 176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Minakshi |
| Designation |
Professor |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh |
| Address |
Room no-218,Anatomy block RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh 176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017565 |
| Fax |
|
| Email |
drminakshi2050@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjul Sharma |
| Designation |
PG Scholar,Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh |
| Address |
RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal Pradesh 176115 India
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418308908 |
| Fax |
|
| Email |
manjul150787@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt. Kangra, Herbal garden and Herbarium, Research Institute in ISM, Jogindernagar, Distt. Mandi |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College & Hospital,Paprola,Kangra,176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Dr Minakshi |
RGGPG Ayurvedic College,Paprola |
Room no.218 Anatomy block
RGGPG Ayurvedic College and Hospital Paprola HP
Kangra
HIMACHAL PRADESH |
9418017565
drminakshi2050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy infants upto the age of 1 year. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Suvarnaprashan Yoga, Reference: Asgtanga Hridaya Uttra Tantra 1/47-48, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Samangadi Leha, Reference: Kashyap Lehan Adhyaya P.no.7, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1. Apparently healthy children of age upto 1 year, irrespective of gender, religion, and socioeconomic status etc.
2. Parents of study subjects willing to participate in the trial. |
|
| ExclusionCriteria |
| Details |
1. Children above one year of age.
2. Children with any congenital disorder, syndrome etc.
3. Neonatal Anaemia, HIV and HbsAg + newborn
4. Children with acute illness.
5. Parents of the study subjects not willing to participate in the trial |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the comparative effect of Suvarnaprashan Yoga and Samangadi Leha on growth and development of infants. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the clinical safety of Suvarnaprashan yoga & Samangadi leha in infants.
2.Safety will be assessed through pre-clinical study.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/07/2024 |
| 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="0"
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
|
I would like to publish my research trial after completion as soon as possible. A total of 50 subjects will be studied in 2 groups. 50 study subjects will be managed with Suvarnaprashan yoga and 50 study subjects will be managed with Samangadi Leha. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools.
|