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CTRI Number  CTRI/2024/11/076821 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pregnancy Care with Ayurveda with Classical Dance Therapy 
Scientific Title of Study   Integrated Garbhasamskara Protocol with and without Adavu practice on Maternal and Foetal outcome- A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Nidhi Devidas Chickramane 
Designation  PhD scholar Department of Prasuti tantra and Stri roga  
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti Tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road

Jaipur
RAJASTHAN
302002
India 
Phone  9538352333  
Fax    
Email  nidhi.ayurveda1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Bharathi K. 
Designation  Professor and Head of the Department of Prasuti Tantra and Stri Roga 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Department of Prasuti Tantra and Stri Roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road

Jaipur
RAJASTHAN
302002
India 
Phone  9799997940  
Fax    
Email  baruhunt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Nidhi Devidas Chickramane 
Designation  PhD scholar Department of Prasuti tantra and Stri roga  
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti Tantra and Stri Roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer Road

Jaipur
RAJASTHAN
302002
India 
Phone  9538352333  
Fax    
Email  nidhi.ayurveda1@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawarsingh gate Amer road AMER ROAD JAIPUR 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda  
Address  National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur 302002 
Type of Sponsor  Research institution 
 
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 Nidhi Devidas Chickramane  National Institute of Ayurveda  Department of Prasuti tantra and Stri roga OPD Room no 26and27 IPD and Garbhasamskara unit of Department of Prasuti Tantra and Stri roga
Jaipur
RAJASTHAN 
9538352333

nidhi.ayurveda1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O269||Pregnancy related conditions, unspecified. Ayurveda Condition: GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vyAyAmaH, व्यायामः (Procedure Reference: Natyashastra, Procedure details: Loosening Exercise – 10Min Adavu – 15Min Borg RPE -12-14 Scale Abhinaya - Garbhasamvada – 15Min Cooling Exercise Relaxing Exercise and Pranayama- 20Min with Borg RPE 10-12 scale Designed as per ACOG guidelines Total duration 60mins/day ))
(1) Medicine Name: dhatri lauha, Reference: A.F.I.-1:284, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 12 Weeks
(2) Medicine Name: jivanti churna, Reference: API part1:vol4 :32, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 12 Weeks
(3) Medicine Name: gokshura , Reference: API part 1:Vol 1:26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 12 Weeks
2Comparator ArmProcedure-mantra-cikitsA, मन्त्र-चिकित्सा (Procedure Reference: charaka samhita shareera sthana 8/3, Procedure details: Raga Mohana & Kalyani instrument- Flute /Violin/ vocal (Below 60 Db) along with garbha samvada (creative visualization and self-interaction of pregnant women with the foetus) total duration of 60mins per day)
(1) Medicine Name: dhatri lauha, Reference: A.F.I.-1:284, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 12 Weeks
(2) Medicine Name: jivanti churna, Reference: API part1:vol4 :32, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 12 Weeks
(3) Medicine Name: gokshura, Reference: API part 1:Vol 1:26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 12 Weeks
3Comparator Arm (Non Ayurveda)-Standard WHO group1.Supplementary nutritional therapy – Oral administration. Above 10% of hemoglobin 1 tablet ferrous sulphate (Containing 60 mg of elemental iron) Daily once 2.Tablet containing 500 mg elemental calcium and 250 IU Vitamin D3 Each tablet twice daily Duration: 12weeks
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.Women, with age group between 21 to 40 years with single viable pregnancy confirmed by USG.
2.Singleton pregnancy, with gestational age from 20-32nd weeks (Primigravida and multigravida)
3.Participants having H/O Pregnancy induced hypertension, Oligo hydramnios, Poly hydramnios and Intra Uterine growth retardation in previous pregnancy
 
 
ExclusionCriteria 
Details  1.Previous history of any major systemic illness such as H/o chronic respiratory disease, H/o cardiac disease, Tubercular infections and uncontrolled diabetes mellitus.
2.Pregnant women with uterine anomalies such as bicornuate uterus, cervical incompetence and multiple gestation.
3.Pregnancy associated with any gynaecological complications such as cervical fibroid, large ovarian cyst, and genital prolapse.
4.Low lying Placenta, Placenta Previa – Grade 1,2, 3, 4.
5.Pregnant with H/O Cervical incompetence.
6.Participants with H/O bleeding PV (Per Vagina) in the current pregnancy.
7.K/C/O Knee joint, hip joint and Ankle joint affected participants.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maternal outcome- 1. Prevention of PIH, Anaemia
2.Comparison of values with standard care –Umbilical, Uterine artery
3. Comparison of AFI values with Standard Care
Fetal outcome-
1. Changes in Foetal growth: HC, AC, BPD, FL
2. Changes in Doppler velocimetry- PI, RI Index
 
20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS) 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal Outcome:
1.Prevention and changes in Minor ailments
2.Changes in Quality of life- (PROMIS v.1.0/1.1)
Fetal outcomes:
Prevention of IUGR, Oligohydramnios, Polyhydramnios 
20TH WEEK TO 32 WEEK OF GESTATION (12WEEKS) 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   29/11/2024 
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  

Need for the study-

The Grabhasamskara Protocol is a well-established Ayurvedic intervention that has been utilized for promoting maternal and foetal health during pregnancy. This protocol, which includes a combination of dietary recommendations, lifestyle modifications, and herbal supplements, has been shown to have positive effects on both the physical and mental well-being of pregnant women and their unborn children.

Dance therapy is another intervention that has been gaining recognition for its potential benefits during pregnancy[i]. It involves the use of movement and dance as a form of therapy, and it has been shown to have positive effects on both physical and mental health. Studies have shown that Dance can help reduce stress, improve mood, and increase overall well-being in pregnant women Indian classical dance forms have a soothing and emotional impact on the mother, that in turn will have better maternal and foetal outcomes.

Despite the potential benefits of both Gabhasamskara and Dance Therapy, there is limited research on the combined effects of these interventions during pregnancy. Therefore, the need for this study is to investigate the potential synergistic effects of Gabhasamskara with and without classical dance therapy on maternal and foetal health during pregnancy. By examining the combined effects of these interventions, we can gain a better understanding of how they can be used together to promote the health and well-being of pregnant women and their unborn child.

Research Gap Analysis- Lack of empirical evidence exploring the combined effects of Classical Dance Therapy with Gabhasamskara Protocol on maternal and foetal outcomes. Previous studies have primarily focused on either Gabhasamskara techniques or aerobic dance therapy, leaving a notable void in understanding the potential synergistic benefits of integrating both modalities. This trial aims to bridge this gap by providing valuable insights into the efficacy of such integrated approaches, thus addressing a critical gap.

RATIONALE OF THE TRIAL PROTOCOL

The protocol is designed with combination of Physical work- up and emotional expression. As recommended by ACOG physical exercise of 30min regularly have a good impact on labour outcomes.[ii] Addition of the emotional quotient by including enactment of the garbhasamvada, will provide add-on effect by impacting the positive thoughts among the pregnant woman.

Physical Workup -  Classical Dance form like- Bharatanatyam, Kuchipudi, Etc depend on group of hand and leg movements called “Adavu”[iii]. These Adavu are based on the Semi –sitting Posture called Aramandi.  Aremandi, also known as Ardhamandala[iv], is a fundamental posture in Indian classical dance forms, especially in Bharatanatyam and Odissi. The term "Ardhamandi" is derived from the combination of two Sanskrit words: "Ardha," meaning half, and "Mandi," meaning legs and knee joint. Together, Ardhamandi refers to a semi-seated or half-squatting stance that is characteristic of the traditional Indian dance styles.

Details of the Aramandi Posture-

Posture- Semi-squatting position with the knees bent and the weight evenly distributed on both legs. The stance resembles the shape of a partially opened lotus flower.

Body Alignment- The back is kept straight, and the chest is lifted. The head is held in a neutral position with the eyes focused on a specific point.

Symbolism-  This posture symbolizes a sense of rootedness, stability, and connection to the earth. It is considered a strong and foundational stance, providing the dancer with a solid base from which to execute intricate footwork, body movements, and expressions.

Emotional Workup- Garbhasamvada is a part of Gabhasamskar protocol where, the mother is made to imagined to have conversation between Garbha and Herself. In this protocol the process of imagining is made in the form of enactment by the pregnant woman. Thus the woman feels that she is physically doing the enactment of what she does in her imagination. This will enhance the Matrutva bhava among the mothers and thus help in impacting positive outcome in pregnancy. 


Previous Research works:

1.      Effect of aerobic dance on cardiorespiratory fitness in pregnant women: A randomised controlled trial Halvorsen, Silje et al.[v]

2.      Aerobic Exercise and Submaximal Functional Capacity in Overweight Pregnant Women-A Randomized Trial- Santos et al. [vi]

3.      Effect of Garbh Sanskar (Yoga) on Maternal and Perinatal Outcome, Chaudhary A. et allz[vii]

4.      The Effect of Selected Aspect of Gabhasamskara on Stress, Coping Strategies and Wellbeing of Antenatal Mothers, Jyotsna Deshpande et all[viii]

5.      Clinical evaluation of effect of music with creative visualization on foetal growth and maternal physiology with special reference to E.C.G Vaishnav mauli, Usha V.N.K.[ix]

RESEARCH QUESTION:

Is there any change in the efficacy of the Integrated Gabhasamskara Protocol with and Without Adavu practice when compared with Only WHO recommended guideline on maternal and foetal outcome in the 20-32 weeks of gestation? 

Hypothesis-

Gabhasamskara Protocol Study:

Null Hypothesis (H0):

There is no difference in the efficacy of the Integrated Gabhasamskara Protocol with Adavu practice and the Gabhasamskara Protocol without Adavu Practice when compared with only WHO recommended guidelines on maternal and foetal outcome in 20-32 weeks of gestation.

Alternate Hypothesis (H1):

There is a difference in the efficacy of the Integrated Gabhasamskara Protocol with Adavu Practice and the Gabhasamskara Protocol without Adavu Practice when compared with only WHO recommended guidelines on maternal and foetal outcome in the 20-32 weeks of gestation.

Aim:

To evaluate and compare the efficacy of the Gabhasamskara Protocol with Adavu Practice and the Gabhasamskara Protocol without Adavu Practice when compared with only WHO recommended guidelines on maternal and foetal outcome in the 20-32 weeks of gestation.

 

Objectives

Primary objectives

1.      To evaluate and compare the efficacy of integrated garbha samskara protocol and standard Anti-natal care on outcome indicators related to maternal and foetal outcome between 20-32 weeks of Gestational age.

2.      Analytical study of the Gokshurasiddhayavagu and medical intervention during 20-32 weeks of gestation.

Secondary objectives

1.      To evaluate and compare the effectiveness in lowering the maternal complications such as pregnancy induced hyper tension, Anaemia in pregnancy.

2.      To evaluate and compare the effectiveness in lowering the foetal adverse outcomes like Intra Uterine growth retardation, Oligohydramnios and Polyhydramnios etc

3.      To evaluate the effectiveness in maintaining adequate utero placental blood flow.

4.      To evaluate the effectiveness in maintaining quality of life of pregnant women

5.      To compare the dietary intake and nutritional status between pregnant women consuming Gokshurasiddha Yavagu and those not consuming it within the study period.



[i] Bánkyné Perjés, B., Mátrai, G., Nagy, B., Erdei, D., Makai, A., Prémusz, V., Kovács, K. A., & Bódis, J. (2022). Prenatal dance activity enhances foetal and postnatal cognitive and motor development. Physiology International109(4), 486-500. https://doi.org/10.1556/2060.2022.00121

[ii] ACOG Committee Opinion. Exercise during pregnancy and the post-partum period. Number 267, January 2002. American College of Obstetricians and Gynecologists.IntJ Gynaecol Obstet 2002;77:79–81

[iii] Subbulakshmi, S. (2023). Geometrical Motifs in Bharatanatyam. Humanities11(2), 50-53.

[iv] Jyothi, S., & Sujaya, B. (2018). Assessment of muscle strength in female Bharatanatyam dancers. Retrieved from. International Journal of Physiology, Nutrition and Physical Education3, 621-625.

[v] Effect of aerobic dance on cardiorespiratory fitness in pregnant women: A randomised controlled trial Halvorsen, Silje et al. Physiotherapy, Volume 99, Issue 1, 42 - 48 doi:10.1016/j.physio. 2011.11.002.

[vi] Santos, I. A., Stein, R., Fuchs, S. C., Duncan, B. B., Ribeiro, J. P., Kroeff, L. R., ... & Schmidt, M. I. (2005). Aerobic exercise and submaximal functional capacity in overweight pregnant women: a randomized trial. Obstetrics & Gynecology106(2), 243-249.

[vii] Anjali Chaudhary Chaudhary, Umesh Varma, Aditya Varma, Deepali Chaudhary, Devishri Bhatnagar, Niti Agrawal, Jahnvi ShankerEffect of Garbh Sanskar (Yoga) on Maternal and Perinatal OutcomeInt J Med Res Rev2022;10(1):17-23.
Available From
https://ijmrr.medresearch.in/index.php/ijmrr/article/view/1365

[viii] deshpande, Jyotsna Rajendra, Study to assess the effect of selected aspects of Gabhasamskara on stress coping strategies and well being of antenatal mothers of Pune city, International Journal of Science and Research (IJSR) ISSN (Online): 2319-7064 Index Copernicus Value (2013): 6.14 (2013): http://localhost:8080/xmlui/handle/123456789/1746

[ix] Vaishnav Mauli1 , Usha V.N.K, Clinical evaluation of effect of music with creative visualization on foetal growth and maternal physiology with special reference to E.C.G, International Ayurvedic Medical Journal, (ISSN: 2320 5091) (August, 2017) 5(8), Available from, http://www.iamj.in/posts/2017/images/upload/2836_2842.pdf


 
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