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CTRI Number  CTRI/2022/10/046666 [Registered on: 20/10/2022] Trial Registered Prospectively
Last Modified On: 06/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   To evaluate the safety and efficacy of Endotone polyherbal capsule in treatment of Endometriosis. 
Scientific Title of Study   A prospective open label non randomized clinical trial To Evaluate The Safety And efficacy of Endotone polyherbal capsule in treatment of Endometriosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ratibhai Patel 
Designation  Principal Investigator 
Affiliation  Sunflower Women’s Endo Infertility Hospital Pvt Ltd, 
Address  Sunflower Women’s Endo Infertility Hospital Pvt Ltd, Opposite Police Helmet, Drive-in Road Memnagar, Ahmedabad -

Ahmadabad
GUJARAT
380052
India 
Phone  9662512070  
Fax  079-26308105  
Email  drrgpatel@sunflowerhospital.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ratibhai Patel 
Designation  Principal Investigator 
Affiliation  Sunflower Women’s Endo Infertility Hospital Pvt Ltd, 
Address  Sunflower Women’s Endo Infertility Hospital Pvt Ltd, Opposite Police Helmet, Drive-in Road Memnagar, Ahmedabad -

Ahmadabad
GUJARAT
380052
India 
Phone  9662512070  
Fax  079-26308105  
Email  drrgpatel@sunflowerhospital.in  
 
Details of Contact Person
Public Query  
Name  Dr Ratibhai Patel 
Designation  Principal Investigator 
Affiliation  Sunflower Women’s Endo Infertility Hospital Pvt Ltd, 
Address  Sunflower Women’s Endo Infertility Hospital Pvt Ltd, Opposite Police Helmet, Drive-in Road Memnagar, Ahmedabad -

Ahmadabad
GUJARAT
380052
India 
Phone  9662512070  
Fax  079-26308105  
Email  drrgpatel@sunflowerhospital.in  
 
Source of Monetary or Material Support  
Sunflower Women’s Endo Infertility Hospital Pvt Ltd, Opposite Police Helmet, Drive-in Road Memnagar, Gujarat Ahmedabad - 380052 India.  
 
Primary Sponsor  
Name  Charak Pharma Pvt Ltd 
Address  21, Evergreen Industrial Estate, Shakti Mills Lane, Off Dr. E. Moses Road, Mahalaxmi, Mumbai - 400 011. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ratibhai Patel  Sunflower Women’s Endo Infertility Hospital Pvt Ltd,   Opposite Police Helmet, Drive-in Road Memnagar, Gujarat Ahmedabad - 380052 India.
Ahmadabad
GUJARAT 		 9662512070
079-26308103
drrgpatel@sunflowerhospital.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sunflower Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N809||Endometriosis, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Endotone, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 275(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: 1) Musta (Cyperus rotundus) Rhizome 50(mg) 2) Haridra (Curcuma longa) Rhizome 50 (mg) 3)Lodhra (Symplocos racemose) Stem Bark 50 (mg) 4)Ashwagandha (Withania somnifera) Root 40 (mg) 5) Yashtimadhu (Glycyrrhiza glabra) Root 25 (mg) 6) Mandukparni (Centella asiatica) Whole Plant 25 (mg) 7) Twak (Cinnamomum cassia) Bark 15 (mg) 8) Shunthi (Zingiber officinale) Rhizome 2 (mg)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Female 18 to 45 years of age (inclusive) at the time of screening.
2) Women experiencing endometriosis symptoms like pelvic pain, dysmenorrhea,
Dyspareunia
3) Women with documented diagnosis of endometriosis by either of the following -
a) Laparoscopy or laparotomy
b) VAS test score of 1-7 for dysmenorrhea/dyspareunia and/or Pelvic pain due to
endometriosis.
c) Clinical features, pelvic examination findings
d) Diagnosed case of endometriosis by any radio-imaging techniques.
4) Recurrent Endometriosis after surgery 
 
ExclusionCriteria 
Details  1) Participant having chronic pelvic pain that is not caused by endometriosis
2) Patients with concomitant hormonal treatment, including oral contraceptive pills.
3)Patients with known systemic diseases (e.g., hypertension, diabetes, coronary, renal, and
hepatic diseases).
4) Patients with known malignancy.
5) Menopausal women, Pregnancy, Lactating women.
6) Large chocolate cysts  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain reduction in endometriosis  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improved quality of life.  6 Months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   31/10/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Endometriosis is a prevalent disease estimated to affect 10% of women of reproductive age, upto 50% of women with pelvic pain, and 20%-50% of women with reduced fertility. The commonest symptom is pelvic pain, which presents as dysmenorrhea in over 98% of patients with symptomatic endometriosis and non-menstrual pelvic pain. Pelvic pain associated with endometriosis varies greatly in intensity, frequency and duration from patient to patient. Non-menstrual pelvic pain is usually chronic (lasting ≥ 6 months), and it can be intermittent throughout the menstrual cycle or continuous and may present as dull, throbbing, or sharp pain. In addition, the pain related to endometriosis has been shown to impair both work- related and non-work-related daily activities. 
For the present study, a polyherbal formulation manufactured by Charak Pharma Pvt. Ltd. will be taken up for the study. The formulation has been standardized after formulating SOPs along with acute toxicity study. The objective of current study is to assess clinical safety and efficacy of the study drug in symptoms associated with endometriosis.








 
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