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CTRI Number  CTRI/2020/03/024036 [Registered on: 18/03/2020] Trial Registered Prospectively
Last Modified On: 17/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Prachchhana Karma, Maltadya Tail and Dhavadi Kwath in the patient of Alopecia. 
Scientific Title of Study   To study the role of Prachchhana Karma followed by Maltadya Taila along with Dhavadi Kwath in the management of Indralupta w.s.r.to Alopecia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manjari Chandravanshi 
Designation  P.G. Scholar 
Affiliation  Shri narayan prasad awasthi govt ayurvedic college,raipur 
Address  Shri Narayan prasad awasthi Govt Ayurvedic College, Raipur Chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  8120393532  
Fax    
Email  manjarikwd308@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Balendra Singh 
Designation  Reader H O D 
Affiliation  Shri Narayan prasad awasthi govt ayurvedic college raipur chhattisgarh 
Address  Shri Narayan prasad awasthi govt ayurvedic college raipur chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  9039180335  
Fax    
Email  drbalendrasingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satrupa Nirmal 
Designation  Lecturer 
Affiliation  Shri Narayan prasad awasthi govt ayurvedic college raipur chhattisgarh 
Address  Shri Narayan prasad awasthi govtayurvedic college raipur chhattisgarh

Raipur
CHHATTISGARH
492010
India 
Phone  9301088046  
Fax    
Email  rupa.nirmal1985@gmail.com  
 
Source of Monetary or Material Support  
Dept. of Shalya tantra Shri Narayan Prasad Awasthi Govt. Ayurved college Raipur C.G. 
 
Primary Sponsor  
Name  Dept of Shalya tantra Shri Narayan Prasad Awasthi Govt Ayurved college Raipur CG 
Address  Shri Narayan Prasad Awasthi Govt. Ayurved college Raipur C.G 
Type of Sponsor  Other [Shri Narayan Prasad Awasthi Govt. Ayurved college Raipur C.G] 
 
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 
MANJARI CHANDRAVANSHI  Shri Khudadad Doongaji Govt. Ayurved Hospital Raipur C. G.  Opd No- 15 Department of Shalya Tantra, Shri Khudadad Doongaji Govt. Ayurved Hospital Raipur C. G.
Raipur
CHHATTISGARH 
8120393532

manjarikwd308@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L63||Alopecia areata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  - 20 patients will be taken for study. The patients of this group will be managed by Maltadya taila shiroabhayanga along with Dhavadi kwath for shiroprakshalana  Route of administration- Maltadya Taila- Local application Dhavadi kwath-Shiroprakshalana (Head bath) Duration of treatment- Maltadya Taila – Apply daily for 6 weeks. Dhavadi kwath- Apply at the interval of 3 days for 6 weeks Follow up - Once in 15 days for 1 month.  
Comparator Agent  20 patients will be taken for study. The patients of this group will be managed by Prachchhana karma and Maltadya taila shiroabhayanga along with Dhavadi kwath for shiroprakshalan.   Route of administration- Maltadya Taila- Local application Dhavadi kwath-Shiroprakshalana (Head bath) Duration of treatment- Prakshachhana karma- 6 sittings in a gap of 7 days for 6 weeks. Maltadya Taila – Apply daily for 6 weeks. Dhavadi kwath- Apply at the interval of 3 days for 6 weeks Follow up - Once in 15 days for 1 month.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  Age group- 18 to 35 years.
Sex- only male patients are included.
Habitat- Both urban and rural area is selected.
Type of patients-
1.Alopecia areata
2.Early stage of androgenic alopecia
3.Alopecia caused by fungal infection and traction.
 
 
ExclusionCriteria 
Details  Patients having age is less than18 years and above 35 years.
Female patients are excluded.
Patients having history of hair loss due to injury.
Asadhya lakshana has been excluded.
Patients suffering from any severe systemic disease are excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Regrowth of hair
Improve quality of life
 
6 week
 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of treatment related adverse effects and recurrence rate.  6 week 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/03/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hair form an important anatomical structure of the body, derived from ectoderm of skin. Hair is made up of keratin protein. Hair loss is consider the fall of hair from head. In modern science loss of hair known as Alopecia or baldness. There are many types of alopecia depending upon the pattern of hair loss. Two forms of Alopecia-

1.      In Scarring alopecia- There area associated fibrosis, a decreased number of follicular openings.

2.      In Non-scarring alopecia- Reversible nature hair shafts are gone, but the hair follicles are preserved.

            Eg. - Androgenic alopecia, alopecia areata, tinea capitis etc.

The prevalence of alopecia in India is 58% of the male population age between 30-50 years had AGA (Male androgenic alopecia).

In Ayurveda, hair problem described under the broad heading of Kshudra Rogas except Acharya Vagbhata who has mentioned it under Kapal Roga. Alopecia is known as Indralupta or Khalitya or Rujya. Indralupta is loss of hair in form of patches in scalp area. Due to pitta associated with vata reaches Romakupa causes hair fall, later on kapha dosha along with rakta obstructs the Romakupa and restricts their re-growth1.

Acharya charak described that due to vitiation of asthi dhatu khalitya occurs as the mala of asthidhatu is keshya (hair). The Ayurveda suggest many preventive and curative measures for Indralupta Shiroabhyanga, Lepa, Rasayana and Nasya are described. Also Shastra karma like Prachchhana and Siravedha has been adopted for the management of Indralupta. Prachchhana helps in draining the vitiated Rakta and plays an important role in Sampraptivighatana of Indralupta. The application of Maltadya taila on the scalp with finger tips leads to increase the local blood circulation. Dhavadi kwath is used for head bath.

 
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