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CTRI Number  CTRI/2025/06/088051 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 02/06/2025
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   Role of Shuntyadi Yoga in Vibandha with special reference to constipation in children. 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of Shuntyadi Yoga in Vibandha with special reference to constipation in 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 Bharat Ganesh Subhashrao  
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  Department of Kaumarabhritya, Room No. 09, Sri Sri College of Ayurvedic Science and Research Hospital, 21 st Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9975168274  
Fax    
Email  ganeshbharat404@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deshpande Sharvari Sunil  
Designation  Associate professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  Department of Kaumarabhritya, Room No. 09, Sri Sri College of Ayurvedic Science and Research Hospital, 21 st Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9901059707  
Fax    
Email  drsharvarideshpande@icloud.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deshpande Sharvari Sunil  
Designation  Associate professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore 
Address  Department of Kaumarabhritya, Room No. 09, Sri Sri College of Ayurvedic Science and Research Hospital, 21 st Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore KARNATAKA 560082 India

Bangalore
KARNATAKA
560082
India 
Phone  9901059707  
Fax    
Email  drsharvarideshpande@icloud.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research,21st km Kanakapura Road, Udayapura P.O, Bangalore- 560082 , India 
 
Primary Sponsor  
Name  Dr Bharat Ganesh Subhashrao 
Address  Department of Kaumarabhritya, Room No. 09, Sri Sri College of Ayurvedic Science and Research Hospital, 21 st Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore KARNATAKA 560082 India 
Type of Sponsor  Other [[SELF]] 
 
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 Bharat Ganesh Subhashrao  Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore  Department of Kaumarabhritya, Room No. 09, Sri Sri College of Ayurvedic Science and Research Hospital, 21 st Kanakapura Road, Udayapura P.O, Bangalore- 560082 Bangalore KARNATAKA 560082 India
Bangalore
KARNATAKA 
9975168274

ganeshbharat404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shuntyadi Yoga, Reference: Pandit SBM. Bhavprakasa of Sri Bhavamisra. Part 2. Madyam khanda. Chapter 6. Jatharaagnivikara adhikara. Varanasi: Chaukhambha Sanskrit Sansthan; 8th Reprint ed.p. 77., Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Guda (jaggery powder)), Additional Information: -drug dose will vary according to age of patient.
2Comparator ArmDrugClassical(1) Medicine Name: Aragwadhadi Avaleha , Reference: Tripathi R. Charak Samhita. Part 2. Kalpasthana. Chapter 8. Verse 12. Chaukhamba Sanskrita Pratishtan : Delhi. Reprint ed. 2013, p. 842., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Ksheera), Additional Information: -drug dose will vary according to age pf patients.
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  1. Children in between the age group of 2 to 6 years irrespective of religion, gender, and
socio-economic status will be included.
2. Children having clinical features of constipation for less than or equal to 2 weeks.
3. Children whose parents are willing to sign the written consent form and to follow the
protocol. 
 
ExclusionCriteria 
Details  1. Children with anatomical malformations of anal canal. e.g. Anal stenosis,
Hirschsprung’s disease, etc.
2. Children who are known case of Inflammatory bowel disease, Irritable Bowel
Syndrome, Neuromuscular disease.
3. Children under drugs that induce constipation or any other long-term medication, e.g.
Opioid pain relievers, Anti-cholinergic agents, Antispasmodics, etc. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant decrease in ‘Vibandha’ ( Constipation ) based on Constipation Assessmnet Criteria and Bristol stool scale.  0th, 15th day, 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Generation of in - depth analysed data on the different aspect of the disease.
2. Generation of data on possible unexpected drug reaction. 
0th, 15th day, 30th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/06/2025 
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  
Nurturing today’s children is essential for a brighter future, as they symbolize tomorrow’s potential. The physical wellbeing of young children has a direct effect on their overall development. Regular defecation is one of the indicators of good health. The normal defecation pattern of children might change according to age and dietary habits. Changes in defecation pattern may cause some physical and psychological problems. Thus, understanding the individual age-related normal and abnormal defecation patterns is considerably important. Understanding Constipation/Vibandha, i.e. infrequent defecation, painful defecation, or both, will help in understanding the overall health of the child. 
The prevalence of childhood constipation in general population varies widely ranging from 0.7% to 29.6%. It accounts for 3% of visits to general Pediatric clinics and accounts for about 25-30% of visits to pediatric gastroenterologists. 
Constipation is gastro intestinal disease, defined as infrequent defecation, painful defecation, or both. Initial painful defecation leads to voluntary withholding which further paves way for prolonged stasis of fecal matter, as a result of this there is increase in its size and consistency thus a vicious cycle is initiated with more pain on defecation and constipation. 
This leads to distress for the child further causing recurrent discomfort in abdomen, reduced appetite also exhibits changes in behavior, such as mood swings and lack of interest in studies or difficulty in concentrating. Constipation is often negatively perceived by peers and possess a significant burden on both the child and parents. So, it is important that the disease is treated at the beginning stage itself before it leads to further complications like painful defecation with partial evacuation and Fissure in Ano. 
Vibandha can be described as Mala Apravrutti due to solidification of Purisha caused by Dushti of Apana Vayu, Annavaha and Purishwaha Srotas. It is seen as one of the symptoms of Udavarta, Anaha, Adhmana and Arsha. In Vibandha there is Purisha Vega Dharana which has the potential to manifest systemic complications such as Pindikodveshta (Calf muscles cramps), Pratishyaya (Coryza), Shiroruja (Headache), Parikartika (Anal fissures), Agnivadha (Loss of digestion capacity) Vatamutra Sanga (Obstruction of urine and flatus) and Hrudgada (Diseases of the heart). Thus, early diagnosis and management of Vibandha is essential for Swasthya of a growing child. 
Main line of treatment according to modern science is considered to be use of laxatives and enema which might temporarily relieve the condition and might reoccur later for the prevention of recurrence long term laxative maintenance is required. Most common side effects of laxatives are excessive gassiness, bloatedness and crampy abdominal pains. Long term use has adverse effects as overstretched or lazy colon which can result in Irritable Bowel Syndrome. The body’s nutrient balance is also negatively impacted by causing a disturbance in mineral balance like magnesium, sodium, potassium, and phosphates, which hamper child’s normal growth and development. 
The treatment principles adapted in Ayurveda are Deepana (Increase the digestive fire), Pachana (Process of Digesting Food), Vata-anulomana (downward movement of Vata) and Rechana (Purgation). There is an impetus to explore the drugs having capacity to cure Vibandha without side effects and recurrence. One such formulation is Shuntyadi yoga mentioned in Bhavaprakasha which is administered with Sahapana of Guda (jaggery). It has main stay on Amajirna, Arsha and Malavibandha by the virtue of its properties. This Yoga is easily acceptable and palatable by children to relieve and prevent Vibandha. Thus, this study is an attempt to evaluate the efficacy of Shuntyadi Yoga on Vibandha in children.
 
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