| CTRI Number |
CTRI/2026/02/104773 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study on the Effectiveness of Moolbandh Practice and Arshakuthara Rasa in Treating Piles (Hemorrhoids) and its association with Prakriti |
|
Scientific Title of Study
|
Effect of Moolbandh and Arshakuthara Rasa in Arsha Management and its association with Prakriti - A Randomized Controlled Trial |
| 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 Tushar |
| Designation |
Pg Scholar Department of Rachana Sharir |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 326 PG Department of Rachana Sharir Chaudhary Brahm Prakash Ayurved Charak Sansthan
South West
DELHI
110073
India |
| Phone |
8527809059 |
| Fax |
|
| Email |
tushar21suryavanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Associate Professor Dr Mukesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 324 PG Department of Rachana Sharir Chaudhary Brahm Prakash Ayurved Charak Sansthan
South West
DELHI
110073
India |
| Phone |
9718505430 |
| Fax |
|
| Email |
dr.mukeshkumarsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Associate Professor Dr Mukesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 324 PG Department of Rachana Sharir Chaudhary Brahm Prakash Ayurved Charak Sansthan
South West
DELHI
110073
India |
| Phone |
9718505430 |
| Fax |
|
| Email |
dr.mukeshkumarsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 110043 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh South West Delhi 110073 |
| Type of Sponsor |
Government medical college |
|
|
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 Tushar |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no 326 PG Department of Rachana Sharir Chaudhary Brahm Prakash Ayurved Charak Sansthan
South West
DELHI |
8527809059
tushar21suryavanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Ch. Brahm Prakash Ayurved Charak Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arshakuthara Rasa, Reference: Yoga Ratnakar 7/1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Moolbandh | (Procedure Reference: Gherand Samhita 3/14-17, Procedure details: (Procedure Reference: Gherand Samhita 3/14-17, Procedure details: Moolabandha with Puraka Kumbhaka Rechaka 15 Minute Protocol 1️ Purpose To standardize a brief 15 minute Moolabandha practice integrating breath control in 1 4 2 ratio for pelvic floor strengthening and mind-body regulation 2️ Requirements Comfortable clothing Quiet ventilation-controlled setting 3️ Starting Position Sitting in sukhasan position Spine erect, shoulders relaxed Eyes gently closed 4️ Breathing Ratio Puraka Kumbhaka Rechaka 1 4 2 as given in hatha yoga Pradipika Example beginner timing Poorak inhale 4 seconds Kumbhak hold 16 seconds Rechak exhale 8 seconds 1 cycle 28 seconds 10 cycles in 5 minutes Adjust seconds based on patient comfort No strain or effortful retention 5️ Technique During Kumbhaka breath retention Apply Moolabandha Phase Action Puraka Deep inhalation through nose for 4 sec having pelvis relaxed Kumbhaka Hold breath for 16 sec Contract and lift pelvic floor muscles upward and inward ie Moolabandha maintain gentle contraction Rechaka Slowly exhale through nose 8 sec Release contraction and relax completely Repeat continuously for 5 minutes Before and after during the course of moolabandha application there would be 5 minute of normal breathing in resting position )
)
(1) Medicine Name: Arshakuthara Rasa, Reference: Yoga Ratnakar 7/1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 20-60 years
2 Diagnosis: Hemorrhoids Grade I II III
3 Willingness to participate: Patients willing to practice Moolbandh and attend follow-up sessions.
4 Subjects who are ready to give consent for digital rectal examination and proctoscopy.
|
|
| ExclusionCriteria |
| Details |
1 Severe hemorrhoids that require immediate surgical intervention.
2 Anal fissures or fistulas Patients with anal fissures or fistulas.
3 Pregnancy or breastfeeding Pregnant or breastfeeding women.
4 Concurrent therapies Patients undergoing concurrent therapies for hemorrhoids (e.g. rubber band ligation, sclerotherapy).
5 Patient who are suffering with diabetes mellitus Tuberculosis HIV Hepatitis B and other congenital diseases malignancy cases.
6 Patients below 20yrs and above 60yrs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 This study highlights the importance of assessing the association of prakriti with the therapeutic effects of moolabandha in Guda Arsha patients
2 Improved Pelvic Floor Muscle Strength
Regular practice of Moolbandha is anticipated to enhance the tone strength and coordination of the pelvic floor muscles
3 Reduction in Hemorrhoid Symptoms.
4 Participants are expected to report a significant decrease in common symptoms of hemorrhoids
|
First assessment on 0 th day
Second assessment on 15 th day
Third assessment on 30 th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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
|
This randomized controlled trial will evaluate the effect of Moolbandh and Arsha Kuthara Rasa in the management of Arsha or hemorrhoids and assess its association with Deha Prakriti. Hemorrhoids are common anorectal conditions characterized by pain bleeding constipation and discomfort. Ayurveda emphasizes individualized treatment based on Prakriti ie body constitution which may influence disease susceptibility and therapeutic response. Moolbandh is a yogic pelvic floor contraction technique is believed to strengthen perineal muscles improve anorectal circulation and regulate Apana Vayu while Arsha Kuthara Rasa is a classical Ayurvedic formulation indicated for hemorrhoids. A total of 70 patients aged 20 to 60 years diagnosed with Grade I to III hemorrhoids will be randomly divided into two groups. The control group will receive Arsha Kuthara Rasa 2 g per day for 30 days while the intervention group will receive Arsha Kuthara Rasa along with standardized Moolbandh practice for 30 days. Assessment will be done through symptom scoring Digital Rectal Examination DRESS scoring system and Proctoscopy. Prakriti assessment will be conducted using the CCRAS standardized proforma. Statistical analysis will compare therapeutic outcomes between groups and evaluate the association between Prakriti and treatment response. The expected outcome of the study is a greater reduction in hemorrhoidal symptoms and improvement in anal sphincter tone and pelvic floor strength in the group practicing Moolbandh.The study also expects to identify whether specific Prakriti types show better therapeutic response. |