| CTRI Number |
CTRI/2024/06/069474 [Registered on: 25/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Reduce or Resolve the size of Ovarian cyst with use of Ayurvedic Treatment |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Clinical Study to Evaluate the Efficacy Of Shothahara Mahakashaya Ghanvati and Palashadi Yog Basti in the management of Beej kosha Granthi w.s.r Ovarian Cyst |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
| Address |
OPD No 15 Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7404240411 |
| Fax |
|
| Email |
priyankawadhwa653@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor and H.O.D Department of Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
| Address |
Room No 112 PG Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
| Address |
OPD No 15 Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7404240411 |
| Fax |
|
| Email |
priyankawadhwa653@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR AYURVED STUDIES AND RESEARCH UMRI ROAD SECTOR 8 KURUKSHETRA |
|
|
Primary Sponsor
|
| Name |
Priyanka |
| Address |
OPD No 15 Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
| 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 Priyanka |
Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra |
OPD No 15 Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA |
7404240411
priyankawadhwa653@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: GRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: CHARAK SIDDHI STHAN- 3/44-45, Procedure details: Palashadi Yog Basti –Anuvasan Basti with Murchit Til tail 3 pala (Approx.120ml) after meal And Palash Niruhu Basti 520ml before meal, for 8 days (5 Anuvasan and 3 Palashadi Niruhu by Yog Basti sequence mentioned in Charak Samhita) will be administered through rectal route after abhyang and swedan of kati pradesh in every cycle, till 3 menstrual cycle. )
(1) Medicine Name: SHOTHAHARA MAHAKASHAYA GHANVATI, Reference: CHARAK SUTRA-4/15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 3 Months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHOTHAHARA MAHAKASHAYA GHANVATI, Reference: CHARAK SUTRA-4/15, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -LUKEWARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients having cysts size less than or equal to 8 cm as per USG report (persist at least for 2 consecutive cycles)
Single or multiple cysts/ unilateral or bilateral/ unilocular/ multilocular ovarian cysts
Patients either asymptomatic or having clinical sign and symptoms of ovarian cysts
Women with Hb more than 8gm/dl
Patient willing to participate in trial |
|
| ExclusionCriteria |
| Details |
Patients having cyst size more than 8 cm as per USG report
Women with HB less than 8gm/dl
Tubo-ovarian mass Dermoid cyst Para-ovarian cyst Endometriotic cyst Haemorrhagic Cyst Malignant tumours and Fibroid
Patient with uncontrolled HTN TB DM and any other systemic diseases
Patients with CA-125 more than 50 units/ml
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO RESOLVE OR REDUCE THE SIZE OF OVARIAN CYST
TO IMPROVE THE SIGN AND SYMPTOMS ASSOCIATED WITH OVARIAN CYST |
TO RESOLVE OR REDUCE THE SIZE OF OVARIAN CYST
TO IMPROVE THE SIGN AND SYMPTOMS ASSOCIATED WITH OVARIAN CYST |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CHANGES IN OTHER ASSOCIATED CLINICAL FEATURES RELATED TO OVARIAN CYST |
FOLLOW UP FOR SUBJECTIVE SYMPTOMS AFTER EVERY 1 MONTH AND FOR OBJECTIVE SYMPTOMS AFTER 3 MONTH |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/07/2024 |
| 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 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
|
Ovarian Cyst is the most common Emerging disease occurring in the women of Reproductive Age Group Ovarian Cyst is a knotty raised elevation which is nodular or glandular rough swelling, can be neoplastic or non-neoplastic When the follicles (Sacs) in the ovaries do not rupture they form small cysts and called “Simple Cyst Ovarian Cyst is the most common benign neoplasm, found in approximately 20 to 40% women of reproductive age group Though many women are not aware of them but majority women with cyst are asymptomatic but in some women it shows Many symptoms like- Dysmenorrhea, Irregular Menstruation, Lower abdominal Pain, Breast Tenderness, Lower Backache In ayurveda Classics, Special reference of granthi of female reproductive system is not available, but i) Granthi described in samhitas can be considered and treated according to their doshas involvement ii) On the basis of its origin beejkosha (Ovary) and its surrounding, it can be compared with beejkosha granthi When Rakta, Mamsa & meda are vitiated by Tridoshas that are admixed with Kapha produce round, glandular , protuberant, knotty and firm swelling called granthi Such Clinical entity can be Ovarian Cyst where vatadosha is the predominant pathological factor being the natural site of its location (Basti Pradesh) in the body The principle of Samprapti Vighatan i.e., to break the pathogenesis is used for the management of ovarian cyst The Protocol for the treatment of ovarian cyst is to dissolve/reduce the size of cyst. Hence, an attempt on Shothahara Mahakashaya described by Acharya Charaka we convert in ghanvati Formation for Trial and Palashadi yog basti mentioned in Charaka Samhita
|