| CTRI Number |
CTRI/2025/02/080370 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| 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
|
Nimba Kshara Pratisarana in The Management of Abhyantara Arsha. |
|
Scientific Title of Study
|
Randomized Controlled Trial of Nimba Kshara Pratisarana in The Management of Abhyantara Arsha (Internal Haemorrhoids). |
| 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. Uday Shivaji Lawate |
| Designation |
PhD (Scholar) Shalyatantra |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and hospital Hadapsar Pune. |
| Address |
Department of Shalyatantra MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9011854248 |
| Fax |
|
| Email |
drudaylawate3421@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamlakar Vasant Gajare |
| Designation |
BAMS MS PhD Shalyatantra Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and hospital Hadapsar Pune. |
| Address |
HOD Shalyatantra Department Sumatibhai shah Ayurved Mahavidyalaya Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822071732 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kamlakar Vasant Gajare |
| Designation |
PhD Shalyatantra Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and hospital Hadapsar Pune. |
| Address |
Head of Department of Shalyatantra MAMs Sumatibhai shah Ayurved Mahavidyalaya Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9850123482 |
| Fax |
|
| Email |
drgajarekv@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai shah Ayurved Mahavidyalaya Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
MAMs Sumatibhai shah Ayurved Mahavidyalaya Hadapsar Pune. |
| Address |
Survey No. 165-A, Tupe Patil Rd, Malwadi, Hadapsar, Pune, Maharashtra 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Uday Shivaji Lawate |
MAMs Sumatibhai shah Ayurved Mahavidyalaya Hadapsar Pune |
Department of Shalyatantra MAMs Sumatibhai shah Ayurved Mahavidyalaya, Survey No. 165-A, Tupe Patil Malwadi, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA |
9011854248
drudaylawate3421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Apamarga Kshara Pratisarana Pradhan Karma | (Procedure Reference: Sushruta Samhita, Procedure details: 0th 7th 14th day application once week total 3 settings and observation on 0th 7th 14th 21th and 30th day.)
| | 2 | Intervention Arm | Procedure | - | Nimba Kshara Pratisarana Pradhan Karma | (Procedure Reference: Sushruta Samhita, Procedure details: 0th 7th 14th day application once a week and observation on 0th 7th 14th 21th and 30th day.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Arsha that are Mrudu, Prasruta, Avagadha, Uchrita.
2.I II and III degree Haemorrhoids.
3.Per rectal bleeding.
4.Per rectal Pain.
5.Selection was irrespective of religion, education and socio-economic status. |
|
| ExclusionCriteria |
| Details |
1.Patient of Arsha who is not in between 20 to 60 yrs of age group.
2.Fourth degree Haemorrhoids, external Haemorrhoids, Anal polyp, Anal condyloma.
3.Strangulated or thrombosed pile mass.
4.Rectal infection and neoplasms as well as rectal prolapse.
5.Patients with Pregnancy and Pelvic Pathology.
6.Immune-comprised patients i.e. HIV,HbsAg, Tuberculosis.
7.Known cases of portal hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Nimba Kshara Pratisarana in the management of Abhyantara Arsha (I II III degree Haemorrhoids). |
5 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Nimba Kshara in duration of cessation of symptoms in Abhyantara Arsha(I II & III degree Haemorrhoids). |
5 weeks |
| To compare the effect Nimba Kshara Pratisarana & Apamarga Kshara Pratisarana in the management of Abhyantara Arsha (I II & III degree Haemorrhoids). |
1 & half year |
| To study the side effects of Nimba Kshara & Apamarga Kshara in Abhyantara Arsha (I II & III degree Haemorrhoids). |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="2"
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
|
While working in outpatient section, it is noticed there are more patients with Abhyantara Arsha. In modern medicine for Internal Haemorrhoids sclerotherapy, cryosurgery, rubber band ligation is used but, it needs high cost sophisticated instruments. Even though they have there own disadvantages in such conditions the alternative management for Abhyantara Arsha is Kshara karma procedure that will give relief. Hence the purpose of current study is to evaluate the efficacy of Nimba Kshara Pratisarana in The Management of Abhyantara Arsha. |