| CTRI Number |
CTRI/2019/07/020369 [Registered on: 25/07/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug Ayurveda Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Application of Kshara in Internal Haemorrhoids. |
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Scientific Title of Study
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A COMPARATIVE CLINICAL STUDY OF VASA PRATISARANEEYA TEEKSHNA KSHARA AND APAMARGA PRATISARANEEYA TEEKSHNA KSHARA IN THE MANAGEMENT OF ABHYANTARA ARSHA (INTERNAL PILES) |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfPHKumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
national institute of ayurveda |
| Address |
National Institute of Ayurveda
PG Department of Shalya Tantra department National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India
Jaipur RAJASTHAN 302002 India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
ProfPHKumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
national institute of ayurveda |
| Address |
National Institute of Ayurveda
PG Department of Shalya Tantra National Institute of Ayurveda Jorawar Singh Gate , Madhav Villas Palace , Amer Road Jaipur Rajasthan 302002 India
Jaipur RAJASTHAN 302002 India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Prof P Hemantha Kumar |
| Designation |
Professor and Head of the Department |
| Affiliation |
national institute of ayurveda |
| Address |
NATIONAL INSTITUTE OF AYURVEDA JAIPUR RAJASTHAN MADHAV VILAS JAIPUR
302002
Jaipur RAJASTHAN 302002 India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
National Institute of Ayurveda |
| Address |
Madhav Villas Palace, Amer Road Jaipur RAJASTHAN 302002 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India Indonesia |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Himadri mudgal |
National Institute of Ayurveda Hospital Jaipur Rajasthan |
SHALYA TANTRA DEPARTMENT
OPD NO-28 Jaipur RAJASTHAN |
8279248738
drhimadrimudgal52@gmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, NIA |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K629||Disease of anus and rectum, unspecified, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Apamarga pratisarneeya teekshna kshar |
Application of Apamarga pratisarneeya teekshna kshar in abhyantra arsha in sufficient quantity for L/A application once and after 4 wk follow-up |
| Intervention |
vasa pratisarneeya teekshna kshar |
Application of vasa pratisarneeya teekshna kshar in abhyantra arsha in sufficient quantity for L/A application once and after 4 wk follow-up |
|
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Inclusion Criteria
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| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Internal Arsha between the ages of 20 yrs to 65 yrs. ï‚· Patients of Internal Arsha which are Mridu, Prasrita, Avagada (Deep) and Uchchhrita (Projected). ï‚· Patients of Internal Arsha having Pittaja and Raktaja origin. ï‚· Diagnosed case of Internal Piles of First, second, third degree. |
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| ExclusionCriteria |
| Details |
Patients of Arsha, age less than 20 yrs. and more than 65 yrs. ï‚· Patients with other systemic illness like uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis and Retrovirus positive. ï‚· Grade IV Internal Piles. ï‚· External piles and other associated Ano-rectal diseases. ï‚· Infective and Neoplastic conditions of rectum, Rectal prolapse. ï‚· Pelvic pathology and Pregnancy. |
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
Patients of either sex of 20 to 65 years old diagnosed as Abhyantra arsha(Int. piles) will be selected for relief in sign and symptoms.
|
4 WEEK |
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Secondary Outcome
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| Outcome |
TimePoints |
| Recovery time. b. Time to return to work. c. Parental/patient satisfaction. |
30 days |
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Target Sample Size
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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" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2019 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
not published yet
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Sushruta, the author of Sushruta Samhita, available text in Ayurveda surgical practice, has included Arsha in Ashta-Mahagada1. The drastic change in lifestyle has caused rapid increase in the prevalence of this disease. The incidence rate of this disease is high among people with old age. At least fifty percent of the people over the age fifty years have some degree of symptoms related to piles2. In Sushruta Samhita, the treatment modality for Arsha has been divided into four categories3 i.e. Bheshaja Chikitsa (Medical treatment), Kshara Karma (Caustic Therapy), Agnikarma (Thermal cautery Therapy) and Shastra Karma (Surgery). Kshara Karma is indicated in Arsha which are Mridu, Prasrita, Avagada and Uchchhrita4. Sushruta explained two types of Kshara in treatment of Arsha i.e. Paneeya and Pratisaraneeya5. Sushruta has mentioned twenty six drugs for the preparation of Pratisaraneeya Kshara6. Among them I have selected Vasa Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha (Internal piles). I. AIM To evaluate and compare the efficacy of Vasa Pratisaraneeya Teekshna Kshara and Apamarga Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha. II. OBJECTIVES 1. To evaluate the effect of Vasa Pratisaraneeya Teekshna Kshara in the management of Abhyantara Arsha. 2. To compare the effect of Vasa Pratisaraneeya Teekshna Kshara and Apamarga Pratisaraneeya Teeskhna Kshara in the management of Abhyantara Arsha. 3. To study the prepared Vasa Pratisaraneeya Teekshna Kshara phytochemically. Arms Assigned Intervention Group A - 15 Patients withI0, II0& III0 Abhyantara Arsha. Apamarga Pratisaraneeya Teekshna Kshara Control group Procedure: Apamarga Pratisaraneeya Teekhshna Kshara application. The procedure will be done under L.A/S.A. The Kshara will be applied on individual Int. Pile mass for until it turns Pakwa Jambuphala Varna and then it will be washed with Nimbu Swarasa. Group B - 15 Patients with I0, II0&III0Abhyantara Arsha. Vasa Pratisaraneeya Teekshna Kshara Trial group Procedure: Vasa Pratisaraneeya Teekshna Kshara application. The procedure will be done under L.A/S.A. The Kshara will be applied on individual Int. Pile mass until it turns Pakwa Jambuphala Varna and then it will be washed with Nimbu Swarasa. Post-Operative Treatment 1. Triphala Guggulu 500 mg. twice daily after meal for 7 days 2. Laxative- Haritaki Choorna 5 gm. at bed time for 7 days with luke warm water. 3. Warm Sitz bath by Tankan Bhasma 1/2 tsf - twice daily for 7 days 4. Yasthimadhu Taila Matra Basti 15 ml. twice daily for 7 days. 5. Yasthimadhu Taila for P/R Pichu twice daily for 7 days Method of Preparation of Apamarga / Vasa Pratisaraneeya Teekshna Kshara15: The Panchanga of Apamarga / Vasa plant will be collected, dried up and burnt. Then this ash will be collected and mixed with six times of water and filtered 21 times. When the filtrate shall be clean and clear like Gomutra Varna and it will be kept on mild fire and reduced to 2/3rd. Then red hot Shukti (weight 1/10th part of ash) shall be added into the filtrate solution and will be continuously stirred well until it shall reduce to 1/3rd. This shall be further heated up by adding Chitraka Kalka (weight 1/10th part of Shukti). Thick solution will be obtained and this is known as Apamarga /Vasa Pratisaraneeya Teekshna Kshara. It will be collected and stored in air tight container. Procedure of Kshara application : The patient will be placed in lithotomy position on operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with sterilized cut sheet. After then local infiltration anesthesia will be given. With the help of Ghrita smeared Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vasa or Apamarga Kshara will be applied over the pile mass with the help of Darvimukha Shalaka under direct vision. As soon as applying the Kshara, the opening of the Arsho Yantra will be closed by cotton swab and wait for a period of hundred Matra Kala. When the colour of pile mass is looked like Pakwa Jambhuphala, the extra Kshara will be washed out with freshly prepared Nimbu Swarasa. Later the anal packing will be done with Yashtimadhu Taila Pichu. All the pile masses will be applied in a single sitting. 13 ASSESSMENT CRITERIA A. Subjective Parameters: a. Ruja (Post operative pain) b. Raktashrava (Bleeding) B. Objective Parameter: a. Size of the pile mass. b. Colour of pile mass. c. Anal sphincter tonicity (by Hemantha Kumar Modified Sphincterometer) C. Secondary Outcome Measures a. Recovery time. b. Time to return to work. c. Parental/patient satisfaction. |