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CTRI Number  CTRI/2021/03/032166 [Registered on: 19/03/2021] Trial Registered Prospectively
Last Modified On: 01/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Pharmaceutico-Analytical and Clinical study of Saubhagyadi Gutika on Pain during menstruation  
Scientific Title of Study   A Pharmaceutico-Analytical and Clinical study of Saubhagyadi Gutika on Kashatartava w.s.r. to Dysmenorrhea 
Trial Acronym  PACSK/KP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanchan Pal 
Designation  MD Ayurveda Research Scholar 
Affiliation  State ayurvedic college and hospital, Lucknow, Uttar Pradesh 
Address  PG Department of Rasashastra and Bhaishjya Kalpana,State ayurvedic college and hospital

Lucknow
UTTAR PRADESH
226003
India 
Phone  8887857892  
Fax    
Email  kanchi.dr6693@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ram Sagar 
Designation  Lecturer PG Department of Rasashastra and Bhaishjya Kalpana 
Affiliation  State ayurvedic college and hospital, Lucknow, Uttar Pradesh 
Address  PG Department of Rasashastra and Bhaishjya Kalpana,State ayurvedic college and hospital

Lucknow
UTTAR PRADESH
226003
India 
Phone  9451586111  
Fax    
Email  goodluckramsagar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kanchan Pal 
Designation  MD Ayurveda research scholar 
Affiliation  State ayurvedic college and hospital, Lucknow, Uttar Pradesh 
Address  PG Department of Rasashastra and Bhaishjya Kalpana,State ayurvedic college and hospital

Lucknow
UTTAR PRADESH
226003
India 
Phone  8887857892  
Fax    
Email  kanchi.dr6693@gmail.com  
 
Source of Monetary or Material Support  
State Ayurvedic college and hospital,Tulsidas marg,Turiaganj,Lucknow,226003 
 
Primary Sponsor  
Name  State Ayurvedic College and Hospital Lucknow 
Address  State Ayurvedic College and Hospital,Tulsidas Marg, Lucknow 
Type of Sponsor  Research institution and hospital 
 
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 Kanchan Pal  State Ayurvedic College and Hospital, Tulsidas marg, Turiaganj, Lucknow  Opd no. -1 ,Prasuti Tantra and Stri Roga department,State Ayurvedic College and Hospital, Lucknow
Lucknow
UTTAR PRADESH 		 8887857892

kanchi.dr6693@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethic committee, State Ayurvedic College and Hospital, Lucknow   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: Kashtartava,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable   Not applicable  
Intervention  Saubhagyadi Gutika  Dose: Two Tab of Saubhagyadi Gutika (250mg each) BD before 7 days of menses and during menses. • Duration of treatment:- 3 consecutive menstrual cycle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patients who are suffering from primary dysmenorrheal.
2. Patient comes with chief complaint of pain during menses along with associated
symptoms.
3. Patients within the age group 18-40 years.
4. Patients suffering for more than 3 consecutive cycles.
5. Patient with H/O using analgesics and other drug during menses. 
 
ExclusionCriteria 
Details  1.Patients below 18 and above 40 years of age.
2. Patients suffering from secondary dysmenorrhea; having organic pathology of uterus
and adenexa. e.g.- Fibroid uterus, carcinoma of endometrium, venereal diseases ,PID,
adenomyosis, endometriosis etc.
3. Patients suffering from systemic diseases.
4. Patient using intra uterine contraceptive devices.
5. Those under any hormonal therapy.
6. Patients having Pain abdomen associated with excessive bleeding p/v.
7. Patients with H/O thyroid dysfunction. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess the efficacy of Saubhagyadi Gutika
2.To assess the efficacy of trial drug on subjective parameter severity of pain,duration of pain,site of pain, nature of pain 		 Final assessment will be done after completion of trial of four consecutive menstrual cycles.  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of trial drug on associated symptoms Praseka (Nausea),Chhardi (Vomiting),Vibandha (Constipation) ,Atisara (Diarrhea),Aruchi (Loss of
appetite),Shrama (Fatigue),Shirashula (Headache),Vankshana Shula (tenesmus of the bladder), Kati Shula,
and Janu Shula,Swedadikya (excessive sweating),Tamodarshana (Faints) 		 Follow up- each menstrual cycle during trial. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2021 
Date of Study Completion (India) 15/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   The finding of the study will be published in index and peer reviewed journal  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The synopsis entitled as- “A pharmaceutico-Analytical and Clinical study of Saubhagyadi Gutika on Kashtartava w.s.r. to Dysmenorrhoea”

Aims and Objective of the study :-

1. To prepare Saubhagyadi Gutika and established its SMP.

2. To conduct Analytical study of Saubhagyadi Gutika.

3. To evaluate the Clinical efficacy of Saubhagyadi Gutika on Kashatartava (dysmenorrhea).

 PLAN OF STUDY

Pharmaceutical study:

Sources - Collection of raw materials by genuine sources. Saubhagyadi Gutika will be prepared in the Rasa-Shala attached with PG department of Rasa-shastra & Bhaishajya Kalpana, State Ayurvedic College & Hospital Lucknow.

Contents of formulation for each batches:- Saubhagyadi Gutika is mentioned in “Rasa Tantra Sar va Siddha Prayoga Sangrah”. The formulation has six content Suddha Kaseesa, Shuddha Tankan, Shuddha Hingu, Yavani,Krishnamarich, Aelua(Kumari Satva) in the ratio of 1:1:1:2:3:5. Minimum three sample of Saubhagyadi Gutika will be prepared for study.

Analytical Study

In this study all the drug sample and formulation will be analyzed on this parameters.

Organoleptic analysis:- Colour, Taste, Odour, Form etc.

Physico-chemical analysis:- Hardness, Uniformity of weight, Loss on drying ,Water-soluble extract, Alcohol soluble extractives, Total Ash value ,Acid insoluble ash, TLC ,Disintegration time etc. as per availability.

Design of Clinical Study

Sample Sources -All the patients will be selected from the OPD and IPD of PG department of Prasuti Tantra and Stri Roga.

Type of study- Single arm open clinical trial.

Sample size- Minimum 30 patients

Duration of treatment :- 3 consecutive cycle

Follow-up:- On the clearance of next one successive menstrual cycle after completion of trial.

CRITERIA TO BE ADOPTED

Patient comes with chief complaint of pain during menses along with associated symptoms.

Inclusion Criteria

1. Patients who are suffering from primary dysmenorrhea.

2.  Patient comes with chief complaint of pain during menses along with associated symptoms.

3.  Patients within the age group 18-40 years.

4. Patients suffering for more than 3 consecutive cycles.

5. Patient with H/O using analgesics and other drug during menses.

Exclusion Criteria

1. Patients below 18 and above 40 years of age.

2. Patients suffering from secondary dysmenorrhea; having organic pathology of uterus and adenexa. e.g.-

Fibroid uterus, carcinoma of endometrium, venereal diseases, PID, adenomyosis, endometriosis etc.

3.  Patients suffering from systemic diseases.

4.  Patient using intra uterine contraceptive devices.

5.  Those under any hormonal therapy.

6.  Patients having Pain abdomen associated with excessive bleeding p/v.

7.  Patients with H/O thyroid dysfunction.

 

ASSESSMENT CRITERIA

Cardinal Symptoms

 Severity of pain, Duration of pain, Site of pain (lower abdomen, back, thighs & legs),Nature of pain

Associated symptoms

Praseka (Nausea),Chhardi (Vomiting),Vibandha (Constipation) ,Atisara (Diarrhea),Aruchi (Loss of appetite),Shrama (Fatigue),Shirashula (Headache),Vankshana Shula (tenesmus of the bladder), Kati Shula,and Janu Shula, Swedadikya (excessive sweating), Tamodarshana (Faints)

 

CRITERIA OF ASSESSMENT:

The improvement in the patient will be assessed mainly on the basis of relief in the signs and symptoms of the disease. To assess the effect of therapy

 objectively, all the signs and symptoms are given scoring depending upon their severity. Dysmenorrhoea, the cardinal symptom will be assessed on its severity

 and duration of persistence. Other associated symptoms according to Ayurveda as well as per modern, will also be assessed by the scoring method.

A special SCORING PATTERN will be applied in symptoms along with Visual Analog Scale, WaLIDD SCORE.

 

CRITERIA FOR WITHDRAWAL:

1. During the course of trial if any serious condition or any serious adverse effects occurs and that requires urgent treatment.

2. Subject herself wants to withdraw from the clinical trial.

3. Irregular follow-up.

 

ASSESSMENT OF TOTAL EFFECT OF THERAPY:

Based on the assessment of the symptoms, the total effect of therapy is evaluated and grouped according to the following criteria.

 Complete Improvement -    100 % relief in clinical symptoms

 Marked Improvement -       75 - 100 % relief in clinical symptoms

 Moderate Improvement -    50 - 75 % relief in clinical symptoms

 Mild Improvement -            25 - 50 % relief in clinical symptoms

 No improvement -                0 - 25 % relief in clinical symptoms.

 

STATISTICAL ANALYSIS :- The documented observations and findings of the study will be assessed by using statistical analysis to set up the efficacy of the trial drug.

 

 
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