| CTRI Number |
CTRI/2024/03/064746 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assess the Determinants of Ahara (Diet) and Sangeet (Music) Which Affect Behavior of Foetus in-Utero |
|
Scientific Title of Study
|
A Cross Sectional Research to Assess the Determinants of Ahara (Diet) and Sangeet (Music) Which Affect Behavior of Foetus in-Utero |
| 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 Soni Kapil |
| Designation |
Professor, MD Ayu, Ph.D. |
| Affiliation |
Himachal Pradesh University |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital, Paprola PG Department of Prasuti Tantra avum Stri Roga
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Soni Kapil |
| Designation |
Professor, MD Ayu, Ph.D. |
| Affiliation |
Himachal Pradesh University |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital, Paprola PG Department of Prasuti Tantra avum Stri Roga
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Sharma |
| Designation |
MS Scholar |
| Affiliation |
Himachal Pradesh University |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital, Paprola PG Department of Prasuti Tantra avum Stri Roga
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7011724986 |
| Fax |
|
| Email |
swatixsharma1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College & Hospital, Paprola, Distt. Kangra, HP |
|
|
Primary Sponsor
|
| Name |
Dr Vijay Chaudhary Principal |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College & Hospital, Paprola, Distt Kangra, HP |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Prasuti Tantra avum Stri Roga |
RGGPG Ayurvedic College & Hospital, Paprola, Distt Kangra, HP |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soni Kapil |
RGGPG Ayurvedic College & Hospital |
OPD and IPD of Department of Prasuti Tantra avum Stri Roga, RGGPG Ayurvedic College & Hospital, Paprola, Distt Kangra, HP
Kangra
HIMACHAL PRADESH |
9418499799
skbhardwaj73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Dist Kangra Himachal Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Other general sign and symptoms |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Powdered Sugar, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Powdered Karela, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women who give consent for study irrespective of parity.
Subjects in her 3rd trimester of pregnancy (32 to 38 weeks).
Subject having an uneventful antenatal period. |
|
| ExclusionCriteria |
| Details |
1. Subjects less than 20 years and more than 35 years.
2. Subject with onset of labour pains.
3. Subject with bad obstetric history or having any associated medical/ surgical ailment with pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To authenticate the literary references in ayurvedic texts and classics supporting the theory that foetus in-utero can actually can actually taste the food consumed by the mother and perceive the sounds heard by her during the pregnancy. |
1.5 to 2 hours in two consecutive phases during a routine ANC visit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ayurvedic principles
can be brought into the mainstream practice with full conviction in order to provide better antenatal care to the pregnant women through Ayurveda so that a healthy and intellectual progeny can be attained.
|
1.5 to 2 hours in two consecutive phases during a routine ANC visit. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2024 |
| 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="0"
Months="0"
Days="1" |
|
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
|
Research Report will be soon published after the completion of trial 60 subjects fulfilling the Inclusion and Exclusion criterias will be randomly selected from the OPD and IPD of Department of Prasuti Tantra avum Stri Roga, RGGPG Ayurvedic College & Hospital, Paprola.Subjects will be divided into two groups of 30 each. Group 1- Capsule Powdered Sugar 500 mg 2 stat (Combined dose- 1 gm) with water along with Musical Intervention- Raga Darbari via headphones. Group 2- Capsule Powdered Karela 500 mg 2 stat (Combined dose- 1 gm) with water along with Musical Intervention- Shiva Tandava (Aarambh Hai Prachand)
Duration of Assessment will be about 1 1/2 - 2 hours in two consecutive phases of routine ANC visit.
Result will be assessed on the basis of objective assessment criteria. |