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CTRI Number  CTRI/2023/09/057947 [Registered on: 22/09/2023] Trial Registered Prospectively
Last Modified On: 21/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the efficacy of Dashamooladi Shodhanbasti - Ayurveda panchakarma procedure - in patients with Artavakshaya i.e.Amenorrhoea,scanty and infrequent menstruation 
Scientific Title of Study   Efficacy of Dashamooladi Shodhanbasti in Artavakshaya - A single blind randomized controlled clinical trial 
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 Salim Musa Mulla 
Designation  Professor 
Affiliation  Ayurvidya prasarak Mandals Ayurvedic Mahavidyalaya  
Address  MUlla Ayurvigyan Hospital Shafaat Bunglow Opp S T Bus stand More Colony Road Uran Islampur Dist. Sangli
Sion Mumbai
Mumbai
MAHARASHTRA
415409
India 
Phone  7588627408  
Fax    
Email  drsmmulla@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. Sujata Jagtap 
Designation  Asso. Professor 
Affiliation  Ayurvidya prasarak Mandals Ayurvedic Mahavidyalaya 
Address  Ayurvidya Prasarak Mandals Ayurveda Mahavidyalaya Sion Mumbai
Ayurveda Mahavidyalaya Sion Mumbai
Mumbai
MAHARASHTRA
400022
India 
Phone  9820556568  
Fax    
Email  sujatashrikantjagtap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Salim Musa Mulla 
Designation  Professor 
Affiliation  Ayurvidya prasarak Mandals Ayurvedic Mahavidyalaya 
Address  MUlla Ayurvigyan Hospital Shafaat Bunglow Opp S T Bus stand More Colony Road Uran Islampur Dist. Sangli
Sion Mumbai
Mumbai
MAHARASHTRA
415409
India 
Phone  7588627408  
Fax    
Email  drsmmulla@hotmail.com  
 
Source of Monetary or Material Support  
Ayurvidya Prasarak Mandals Ayurved Mahavidyalaya Sion Mumbai 
Loknete Rajarambapu Patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Centre , Islampur Dist. Sangli Maharashtra 
Maharashtra University of Health Sciences, Nashik, Maharashtra 
 
Primary Sponsor  
Name  Ayurved Mahavidyalaya 
Address  Ayurvidya Prasarak Mandals Ayurvedic Mahavidyalaya Sion Mumbai 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Salim Mulla  Ayurvidya Prasarak Mandals Ayurvedic Mahavidyalaya  Streeroga Prasutitantra Department, third floor,Near Sion Railway station, Sion Mumbai PIN 400004 ,
Mumbai
MAHARASHTRA 		 7588627408

drsmmulla@hotmail.com 
Dr Salim Mulla  Loknete Rajarambapu Patil Ayurvedic Medical College Hospital P G Institutea and Research Centre  Department of Streeroga Prasutitantra Female ward 1st floor Islampur- Sangli Road , Islampur, Dist. Sangli )IN 415409
Sangli
MAHARASHTRA 		 7588627408

drsmmulla@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
APMs Ayurved Mahavidyalaya. Sion Mumbai,Institutional Ethical Committee  Approved 
Lolenete rajarambapu patil Ayurvedic Medical College, Hospital , P G Institute And Research Centre Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N912||Amenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, (2) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, (3) ICD-10 Condition:N910||Primary amenorrhea. Ayurveda Condition: ARTAVAKSHAYAH, (4) ICD-10 Condition:N911||Secondary amenorrhea. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushruta Sharirsthana 15 -12, Charak sharirsthana 8-4 , Procedure details: Poorvakarma - snehan and swedan Yogabastikarma containing 8 bastis First - Anuvasana basti on evening befor first niruha basti then Niruha basti - in morning empty stomach and anuvasan basti in evening after food for 3 days on last day Anuvasan basti. This will be followed by sansarjanakrama. )
(1) Medicine Name: Dashamooladi Niruhabasti, Reference: Ashtanga Hrudaya Sutrasthana 15/3, Route: Rectal, Dosage Form: Dravaka, Dose: 960(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: Dashamoolasiddha Til OIL, Reference: Charaksamhita siddhisthana 4-4, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: hs, Duration: 5 Days
2Comparator ArmProcedure-anuvAsana-bastiH, अनुवासन-बस्तिः (Procedure Reference: Sushruta Sharirsthana 15 -12, Charak sharirsthana 8-4 , , Procedure details: Procedure details: Poorvakarma - snehan and swedan.Then Anuvasana basti after food.This will be followed by sansarjanakrama. ) )
(1) Medicine Name: Til oil, Reference: Charak Samhita Siddhisthana 4-4,6, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients suffering from menstrual irregularity as Artavakshaya or Rajaksheenata.
2. Patients having primary or secondary amenorrhoea as a symptom.
3.Patients with artavakshaya willing for conception.
2. Patients from 16 to 45 years of age.
 
 
ExclusionCriteria 
Details  1. Patients having haemorrhagic disorders.
2. Patients with congenital & developmental defects of genital tract.
3. Patients with any new growth especially of reproductive system.
4. Patients with known HIV infection & other venereal diseases.
5. Patients having major systemic disorders like diabetes mellitus, tuberculosis,asthama, etc.
5. Pregnant & lactating womens.
7. Patients unfit for the treatment.  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Rajasrava ( Discharge ) Duration
2. Rajasrava( Discharge ) Quantity in terms of pads
3. Intermenstrual period ( Interval between two cycles)
4. Pains during menses
5. Follicle Size
6. Endometrial thickness
7. Changes in Hormonal assays.
8. Improvement in haemoglobin percentage.
9. Changes in weight of the patient.
 		 1. Rajasrava ( Discharge ) Duration -3 months
2. Rajasrava( Discharge ) Quantity in terms of pads & ml - 3 months
3. Intermenstrual period - 3 Months
4. Pains during menses - 3 Months
5. Follicle Size -3 Months
6. Endometrial thickness - 3 Months
7. Changes in Hormonal assays- 3 Months
8. Improvement in haemoglobin percentage - 3 Months
9. Changes in weight of the patient- 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Rajasrava ( Discharge ) Duration
2. Rajasrava( Discharge ) Quantity in terms of pads
3. Intermenstrual period ( Interval between two cycles)
4. Pains during menses
5. Changes in weight of the patient. 		 1.Rajasrava ( Discharge ) Duration - 1 and 2 month
2. Rajasrava( Discharge ) Quantity in terms of pads 1 and 2 month
3. Intermenstrual period ( Interval between two cycles)-1 and 2 months
4. Pains during menses - 1 and 2 months
5. Changes in weight of the patient. 1 and 2 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 
Date of First Enrollment (India)   02/10/2023 
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="0"
Months="8"
Days="22" 
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  
Prevalence of Artavakshaya( Amenorrhoea) is 1.5 to 3 % of female population of reproductive age group. Panchakarma procedure Bastikarma helps to regularise the menstrual cycle. Bastikarma might offer a pure , safe, fast and effective treatment modality. So keeping in mind the ayurvedic basic principles of beejashuddhi this study is to assess the usefulness and effectiveness of dashamooladi shodhanabasti in Artavakshaya patients.
Research question : is dashamooladi shodhanabasti as yogbasti of 8 bastis will be effective in patients suffering from artavakshaya?
Ho: Dashamooladi Shodhanabasti as yogbasti of 8 bastis is not effective in patients suffering from artavakshaya.
H1 : Dashamooladi Shodhanabasti as yogbasti of 8 bastis is effective in patients suffering from artavakshaya.
AIM : To study the Efficacy of Dashamooladi Shodhanabasti in artavakshaya patients.
Objectives : 1.To study  the efficacy of Dashamooladi Shodhanabasti in artavakshaya patients . 2to note the other beneficial effects of bastichikitsa on body as a whole. 3. to note adverse effects of the treatment if any.4. Disease and drug review.
Data collection will be done .
Data analysis and statistical tests application will be done.
Results and discussion will be followed by unbiased conclusion.
           

 
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