| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. | | 2 | Comparator Arm | Drug | Classical | | (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. |